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Transcript: ICMRA-Industry Virtual Workshop on Enabling Manufacturing Capacity in the COVID-19 Pandemic


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Derek Bonner (AV Support): Good morning, everyone, my name is Derek bottom, a member of the team for today's webinar.

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Derek Bonner (AV Support): is just a means of the housekeeping announcement for all attendees is want to let you know how you'll be able to function inside of our webinar today.

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Derek Bonner (AV Support): You are actually in a listen only mode, so you will not be able to access your microphones but you'll be able to hear all content that is coming from our panelists and our scheduled speakers.

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Derek Bonner (AV Support): We have a nice agenda for you ready today we're also going to be choosing a screen share for all slide presentation, so you should be able to see your slides right now and myself currently as a talking head for you.

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Derek Bonner (AV Support): feel free to ask ask any questions throughout the day there is a Q amp a section that's located at the bottom of your window.

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Derek Bonner (AV Support): If you click on that you can go ahead and type in any kind of questions that's going to come to all of our team here in the back of house, we will see them in triage you into more or less a hierarchy of how those came into us.

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Derek Bonner (AV Support): feel free to also there's an option for make sure you're aware of that, you can ask questions anonymously, if you don't feel comfortable attaching your name to them.

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Derek Bonner (AV Support): But I just want to make sure you're aware of that option that you have right there.

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Derek Bonner (AV Support): The chat function in this meeting is more or less can be used as a means of announcements from our room so we'll be able to share with you our closed captioning portion for how you can use that as well as any kind of.

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Derek Bonner (AV Support): Time the updates, for if you having it issues, so you can contact for that kind of purpose.

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Derek Bonner (AV Support): And if you're just experiencing any kind of technical difficulties feel free to reach out to us and a member of our team either myself or Chris sweat or will the whelan will be able to reach back out to you and try to resolve any kind of issues at that time.

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Derek Bonner (AV Support): I would also like to mention this meeting is being recorded so it'll be available, later on, on playback looks like we're getting a couple people signing up now.

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Derek Bonner (AV Support): Our attendees count is still ticking up.

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Derek Bonner (AV Support): And right now i'm going to go ahead and before we officially kick things off, I want to make sure that everybody has access if they needed.

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Derek Bonner (AV Support): To the closed captioning i've shared that with the chat pod for you should see that the link, I want to point out that if you do click on this link it will open up in a secondary window for yourselves, if you.

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Derek Bonner (AV Support): for whatever reason, you wish to see the live captioning coming in, you can go ahead and do that, but it will open up in a separate link for you, we want to make sure that that's available.

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Derek Bonner (AV Support): And I believe we've covered all of our topics, so now i'm going to pass this on off to hammer Cook, who is the Chair of the ICM ra and she'll get us all started, thank you very much.

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Emer Cooke: Thank you very much, Derek and good morning, good evening good afternoon it's a real pleasure to be here as the Chair of the ICM IRA to welcome you to this workshop.

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Emer Cooke: My name is Mr Cook i'm also the Executive Director of the European Medicines Agency, and I really want to highlight what a milestone and meeting this is it's the first time that it.

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Emer Cooke: has actually has met with industry or had a joint workshop together, so it is effectively a milestone meeting.

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Emer Cooke: But it also marks remarkable achievements over the last 18 months in the context of the pandemic where we've had unprecedented vaccine and therapeutics approval.

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Emer Cooke: unprecedented agility on behalf of regulators post approval changes in record time real time sharing of information between regulators, the concept of at distances inspections, to name but a few.

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Emer Cooke: So this meeting is the joint workshop organized by ephemera on the associations of industry industry associations, the I fema.

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Emer Cooke: Bio the by technology innovation organization DC vm and the developing countries vaccine manufacturers network I GPA, the International generic and biosimilars medicines, association and vaccines Europe.

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Emer Cooke: As I mentioned before it has provided a platform to intensify the in practice between regulators and many of you have you would have seen.

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Emer Cooke: The real time impact of these in the in the context of your and all the assessments and the communications.

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Emer Cooke: The purpose of the workshop today is to discuss how we can further collaborate to clarify to streamline to align and harmonize.

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Emer Cooke: regulatory approaches, so that we enable rapid increase in manufacturing capacity, particularly for Cobra 19 therapeutics and vaccines and a more efficient and effective response to the covert 19 global global public health emergency.

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Emer Cooke: Today we hear from regulators and industry, supported by presentations and case studies on what has really worked so far to do with the emergency and challenges that we're all trying to address.

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Emer Cooke: And what I think is also very interesting about today's meeting is that you will hear you will hear from regulators that maybe you don't always hear from so we have case studies.

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Emer Cooke: that have been discussed from regulators from Saudi Arabia from Argentina from.

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Emer Cooke: Brazil, to name but a few of these will be part of the discussion later in the panel sessions, so there were three sessions during the first part of the presentation, the first i'll call it morning, but I know it's afternoon for many and and maybe even evening for others, but.

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Emer Cooke: The first part of the program focuses on presentations and and case studies, focusing on regulated flexibilities risk based approaches case studies and then we'll have a short break followed by three panel discussions on specific topics of interest.

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Emer Cooke: Each session has a moderator who will control the time but i'll keep a close eye to make sure that we are running on time, because when I was looking at these agendas, I have to say.

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Emer Cooke: At time is really going to be off the ethics essence we're trying to fit a lot into the this three hour session at today.

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Emer Cooke: um so without does starbucks mentioned.

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Emer Cooke: The today's session will be recorded, we will also have a workshop report which will be available.

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Emer Cooke: Shortly afterwards we're not committing to a time at the moment, but we will have a public workshop report.

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Emer Cooke: So there will be certainly lots of opportunities to follow up so with that, I would like to hand over to Greg Perry, who I believe will be saying the opening remarks from the industry perspective over to Greg.

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G Perry: Thank you very much and.

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G Perry: For the audience yes i'm Greg Perry i'm the assistant Director General here at I fema.

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G Perry: on behalf of if pma and our sister associations, as well as our colleagues from the biotech developing world vaccine manufacturers and generic and by similar producers we'd like to thank.

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G Perry: him and his leadership for this platform for engagement which, indeed, we see very much as a milestone, as he mentioned, I think, since the beginning of this pandemic.

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G Perry: We have all witnessed many things, and faced many challenges specifically and how we have been able to respond and adapt rapidly.

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G Perry: To this unprecedented public health emergency just a couple of highlighted facts as at the end of June, we have now eight vaccines with wh.

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G Perry: Emergency listing we have 105 covert 19 vaccines in clinical development and 184 in preclinical development as reported by the WHO.

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G Perry: And we also have many more therapeutics in development from antivirals to monoclonal antibodies, which are all being tested globally.

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G Perry: Now the pandemic is not business as usual for any of us scaling up has been a daunting task.

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G Perry: But thanks to a rapid response in the early months and an unprecedented partnership and manufacturing agreements.

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G Perry: production has increased from zero to 3 billion in just six months since the first vaccine approval.

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G Perry: partnerships and collaborations have taken place across the pharmaceutical and vaccine industries, both in developed and developing countries and between.

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G Perry: Companies in developed and developing countries and the good news now is that we are on track to achieve the 11 billion doses of covert 19 vaccines by the end of the year.

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G Perry: In addition, we shouldn't forget that there are some 78 manufacturing and production agreements for coven 19 therapeutics, and these are taking place globally as well.

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G Perry: An interesting fact is who owes international clinical trials regulatory platform, it has reported that there are over 4500.

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G Perry: clinical studies for both vaccines and therapeutics which have been completed or are currently in progress so much work, effort and collaboration for many different stakeholders have been initiated to get us where we are today.

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G Perry: I think it's important We must also not forget to lose the significant work and effort and collaboration undertaken to ensure the continued biopharmaceutical R amp D supply and patient access to the many medicines and vaccines for all other conditions.

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G Perry: At all the pharmaceutical and vaccine companies have been operating and manufacturing in an environment in which supply and distribution chains have been greatly impacted and challenging.

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G Perry: From our perspective, as industry, this joint ignite and industry workshop provides the opportunity to share experiences look at lessons learned.

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G Perry: challenges faced all which have enabled us to respond rapidly in vaccine development manufacturing and registration in record time.

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G Perry: We want to look at best practices that enabled fast forward regulatory processes and ultimately emergency use of medicines and vaccines.

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G Perry: We want to look at who and how we collaborated and what mechanisms were used to make this happen with a special emphasis on the important role of regulatory reliance.

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G Perry: working in partnership and collaboration with national regulatory authorities to define the best science based regulatory strategies for ensuring the availability of covert 19 vaccines and treatments has been and will remain key.

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G Perry: Globally, we are engaging as industries with nationalist regulatory authorities to provide input and feedback on regulated utilities streamline streamlining processes rolling reviews reliance principles all us to accelerate the development and registration of code vaccines and medicines.

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G Perry: These lessons learned, we also hope will help modernize the current regulatory environment and framework to better adapt to scientific and technical innovations in a sustainable fashion and once which will produce best practices for pandemic pretend repentance.

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G Perry: As an industry, we do not see this as a one off event we see this as a continuation of a dialogue that is already started.

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G Perry: And importantly, one that we feel needs to be continued on a more frequent and regulatory basis there will be more challenges, there will be more lessons learned.

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G Perry: And more experiences to share and to analyze this continuous dialogue between industry and regulators is ultimately beneficial for patients for prevention for healthy people, as well as innovation access and regularly regulatory science in general.

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G Perry: Finally, i'd like to say on behalf of all the industry groups represented here today a thanks to all the regulatory authorities and all the individuals for their enormous work and efforts during this pandemic.

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G Perry: So we are looking forward to a very constructive and fruitful dialogue and a continuation of today's discussions, thank you very much.

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Emer Cooke: Thank you very much Greg and we're delighted to have this opportunity to host to co host this meeting.

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Emer Cooke: And, as I mentioned at the start, time is really key so i'm going to immediately hand over to our.

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Emer Cooke: First speakers, and this is a presentation it's a regulatory presentation to start the.

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Emer Cooke: Discussion providing perspectives on the current science and risk based approach employed by if my regulatory authorities and i'll hand over to Sean barie and at Dr corey county from HP era and AMA respectively over to peace.

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Sean Barry: Many times seamer hi everybody, my name is Sean barie quality cmc assessor from the Irish regulator HQ rate and it seems that I want to present the regulator's viewpoints, in conjunction with my colleague document corky anti freemium a.

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Sean Barry: So, before we start just re i'd like to initially time called the industry and regulator colleagues who we have put this workshop together.

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Sean Barry: I mean getting such a workshop organized in a very short few weeks has been very challenging and, indeed, many people have commented it's a similar challenge to getting many of these post approval changes.

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Sean Barry: approved so so quickly it's been quite impressive to get it done within a month or so.

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Sean Barry: And throughout the presentation i'm going to discuss.

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Sean Barry: Money the regulatory flexibilities which have already been introduced during the pandemic and hopefully convince you that regulars are indeed open to introducing.

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Sean Barry: Appropriate reading flexibilities to ensure timely supply of critical vaccines and therapeutics for corporate it.

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Sean Barry: And just an order I would share out there, that this indeed is the start of an ongoing productive dialogue between regulators and industry and shouldn't be viewed as a one off.

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Sean Barry: A one off session, hopefully, it is the start of something or fruitful and productive and so for just go to the next slide please.

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Sean Barry: So to start, I mean as it's already been said that the current band and pandemic is necessitated really significant acceleration to know development timelines and the D companies have identified vaccine candidates RON trials and receive record.

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Sean Barry: In 112 months, and this has never been done before, and this acceleration has been a challenge for industry and also for regulators.

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Sean Barry: But it's been crucial to the time we roll out of vaccines and indeed significant African efforts have been put in place by regulators to implement registry flexibilities and new ways of working.

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Sean Barry: So I mean, in an effort to try and understand what types of retro flexibilities are in use across the network, the network.

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Sean Barry: We sent out a survey to various regulators and it remembers and you can see in the bottom there some of the respondents that replied and.

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Sean Barry: The survey is quite similar to the one that many of the industry colleagues would see that we send to them so i'm just going to spend a few slides.

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Sean Barry: and highlighting some of the responses we see we see from that survey and what it tells us about state of gratitude flexibility at the moment, so if we go to the next slide please.

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Sean Barry: i'm So this is the server was broken into several parts and the first part here's some of the mechanisms off by offered by rectory authorities.

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Sean Barry: And if we look at some of the organization and regulatory flexibilities and we can see a quite a high response so just to point out.

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Sean Barry: The way this is presented is a percentage of the responses in terms of yes, no, maybe, so I wonder percent of respondents indicated that they do have.

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Sean Barry: Quick frequent and continuous engagement with manufacturers not pencil that's really welcome and as we discuss later it's really key and particularly to introducing folks to prove the changes to have this continuous dialogue between regulators and industry.

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Sean Barry: Most agencies provide rolling submissions or other types of expediting render your actions which courses appropriate for pandemic that data can be accessed assessed really in real time as it's being produced.

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Sean Barry: We have various guidelines most agencies provide guidelines specific to the pandemic.

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Sean Barry: Many agencies do have dedicated resources to handle the lifecycle management and that's something i'll touch on that in a little while.

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Sean Barry: The heavy workload from lifecycle management and comparables you protocols or post approval change management is a key feature and again we will touch that around are they useful as opposed to prove the change management protocols to.

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Sean Barry: To help us to prove with changes and.

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Sean Barry: An important point is approved for a post approval changes in the absence of full data and This again is key to.

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Sean Barry: Increasing manufacturing supply when the full data set may not be available at a point in time, that i'm regulators are open to receiving that data post approval, which in many cases, maybe a certain change of mindset, but indeed it is appropriate, during a pandemic.

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Sean Barry: and looking at information sharing with you know with something industry or our break each emotion in a general sense.

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Sean Barry: Agencies replied that they can rely on assessments tear it up by other regulators, but if we drill down a little bit.

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Sean Barry: And while there is an oppressed sharing between rectory authorities high response rate for that for partial reliance.

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Sean Barry: And maybe not so high, and that's something i'll touch on again in another slide and there is how to take her up high interest in participating in joining during your free assessment programs, so if we go to the next slide please.

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Sean Barry: and terms of the cmc data requirements and flexibility to particular requirements, there is, if you can see there it's 100% of many cases in a quite high responses to this, particularly for method validation in terms of.

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Sean Barry: process qualification or validation and most agencies are currently using or allowing the use of platform data prior knowledge to current validation other.

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Sean Barry: approaches to process validation and limited process qualification data based on risk other approaches and interim specifications alternative in process controls and so on and so on, and another key and.

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Sean Barry: I know desire from industry at the bottom, there is, in terms of stability in terms of establishing a shelf life.

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Sean Barry: Based on only on real time data, so you can see their high proportion of regulators are now open to the possibility of.

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Sean Barry: A proven shelf life of a biological product and what the shelf life in excess of the wind time and its diversity data and again that.

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Sean Barry: That is proportionate in terms of trying to expand manufacturing capacity, when the full stability data set may not be available at the time of approval, so if we go to the next slide please.

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Sean Barry: And then, just the last two parts of the survey and focusing on inspections and as we're aware that there has been moved towards.

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Sean Barry: Remote your virtual inspections which was necessitated by the pandemic and most agencies are currently involved in these type of activities and.

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Sean Barry: We will have a dedicated session to that later on in the workshop and then finally just some of the other approaches to exploit cmc changes touched on concurrent foundation.

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Sean Barry: Most regions allow group supplements or two creations and delegations to a certain level requirements, and so, if we go to the next slide please.

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Sean Barry: So some of the take home messages from the survey, I mean, I think you can see from that the majority of agencies have indeed adopted use all for entry flexibilities for code 19 products.

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Sean Barry: And the types of writing flexibilities are quite numerous some of the more important ones, of course, at the rolling submissions and.

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Sean Barry: Something that has come back, I think, is key from engagement with industry is the need for the frequent engagement regulators, this is a common feature.

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Sean Barry: and an important one, particularly when the development time so compressed and the lifecycle management can be quite intense that this frequent engagement really is.

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Sean Barry: required to increase capacity and it's very important and it's welcome that most regulators are open to this type of frequent engagement.

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Sean Barry: and multiple rhetoric and scientific tools are being used when we talk to them the next slide and, in general, in a sort of even sorry actually if you just go back one slide down.

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Sean Barry: yeah so in general and almost in a sort of philosophical change, I suppose, in some sense in that agencies can approve.

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Sean Barry: In the absence of certain data so we're comfortable with the fact that the full data set may not be available at the time, approval.

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Sean Barry: and certain data will be provided post approval and the document with touch again in that in her slides.

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Sean Barry: And, and there is already sharing of information between rectory agencies, however, perhaps reliance on assessment reports from other agencies or joint assessment is somewhat less common, but this is an area for future explorations that we can work on so go to the next slide please.

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Sean Barry: Some of the tools and work practices that we saw as I said, reviews and we're just the authorizations additional authorization.

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Sean Barry: Communication roof inspections sharing reports and post approve the change management protocols, then, if we look at the tools, the alternative process validation approaches.

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Sean Barry: Use of prior knowledge and platform knowledge which is key prediction of shelf life compatibility protocols intro specifications and submission of data post approval, so this is just highlighting the flexibilities that already in place.

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Sean Barry: for coordinating products and go to the next slide please.

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Sean Barry: And just to touch on post approval lifecycle management and as these procedures particular for new products are approved, I guess, without what will be traditionally the full data set.

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Sean Barry: And of course there's going to be an associated increase in lifecycle management activities and just taking an AMA AMA example, if we look there in the left.

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Sean Barry: At some of the posts approved with changes for the vaccines, if we look at number of post approval changes the Left column their groups.

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Sean Barry: And the number of individuals on the right, so if we look for even for commonalities being 108 hundred as opposed to prove the changes I think last week, I mean that's a huge lifecycle management activity in a short space of time.

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Sean Barry: And you can see in the bottom left associated with this increase in life cycle activity is a reduction in the standard timelines to approve these variations This again is a major and other repair regions have their own approaches and again, either within those days.

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Sean Barry: highlighted there either up more rapid approvals can can can be given, so this just highlights the level of activity that's ongoing.

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Sean Barry: And it is recognized that one of the biggest challenge to challenge us to increasing supply is the introduction and multiple the manufacturing sites post approval and would you recognize that obviously the same change has to be approved by multiple authorities and.

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Sean Barry: Ensuring compliance and multiple regions, why rapidly expand supply is a challenge.

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Sean Barry: That we do recognize so as I hope will highlight throughout the rest of this workshop there is scope for further collaboration between regulators and the implementation of of global post approval changes so if we go to the next slide please.

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Sean Barry: And with that i'm going to hand over to document, thank you.

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Evdokia Korakianiti-EMA: Thank you so good morning.

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Evdokia Korakianiti-EMA: Colleagues, and again correct me to hit of quality and safety, the European Space Agency.

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Evdokia Korakianiti-EMA: I will take you through an example from my call it approve oxy where there are a lot of flexibility in place have been used.

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Evdokia Korakianiti-EMA: To accept that approaches to compatibility process validation instability, I asked and discuss practically elements that were highlighted during the survey.

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Evdokia Korakianiti-EMA: results that show presented so one of the key enablers actually the key enable that allows the flexibilities was the scientific data in the ocean, the applicant demonstrated an extensive my function experience and you are providing commercial data a.

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Evdokia Korakianiti-EMA: commercial scale for multiple sites, some of them not intended to be used for Europe and us supporting data using the same process as the same thing.

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Evdokia Korakianiti-EMA: But releasing process, they they were provided from engineering to bbq loads and some interoperability data, this was coupled with a very good understanding and evaluation studies on the process.

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Evdokia Korakianiti-EMA: They have been extensive understanding and establishment of not all non critical prosper me the political process parameters process attributes with acceptance acceptance criteria, there were enhanced controls and it has control strategy, it is a process validation would be completed.

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Evdokia Korakianiti-EMA: In addition to the doshi included and 10 additional submitted to the definition of stability so.

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Evdokia Korakianiti-EMA: The limited written a data available in the system anything with supplemented by really terms the basic data from similar product using similar process and some extrapolation modeling that allowed for establishment often extrapolate the things products.

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Evdokia Korakianiti-EMA: These are the buckets, of course, was pretty was discussed multiple times with regulators, so in terms of the regulatory tools to a used was rocky scientific advisors.

00:27:44.730 --> 00:27:53.070
Evdokia Korakianiti-EMA: To discuss strategy of stability and compatibility and follow up meetings for the rapid scientific advisor with the roku.

00:27:54.090 --> 00:28:08.670
Evdokia Korakianiti-EMA: boxes were becoming available, in addition to literal interviews This allowed that it's a time of day, a granting of the conditional market answer ization a set of mixing it with refused to do data.

00:28:09.630 --> 00:28:18.270
Evdokia Korakianiti-EMA: And the data, the rest of the data packets was supplemented through specific obligation and other regulatory ricotta you know in our availability.

00:28:19.230 --> 00:28:29.430
Evdokia Korakianiti-EMA: And mikey was her ization also included possible vaccines management protocols what size, a post approval for the APP disk subsystem the finished product.

00:28:30.540 --> 00:28:36.420
Evdokia Korakianiti-EMA: and also an assessment were used to shooting the compliance of certain sites.

00:28:37.470 --> 00:28:49.980
Evdokia Korakianiti-EMA: Both during the marketer initial market authorization and post approval we also use the exemption from QC testing from the a requirement for QC testing is a muscle transfer was in place.

00:28:52.140 --> 00:29:00.240
Evdokia Korakianiti-EMA: In addition to this regulatory tools we had very intense interaction with the applicant and post approval weekly interactions man came to supply.

00:29:00.900 --> 00:29:11.550
Evdokia Korakianiti-EMA: and discuss about accelerated timelines, which was the benefits of seeds, we managed to have an accelerated approval of thing we get in the semiconductor ization.

00:29:12.180 --> 00:29:24.750
Evdokia Korakianiti-EMA: was partially completed bbq and agree on a concrete validation of the commercial construction process, in addition, the finished product sex life was established using extrapolated data.

00:29:26.040 --> 00:29:36.120
Evdokia Korakianiti-EMA: Post approval soon after that other box was complimented for this specific applications post approval, we had a rabbit approval of your slides I had to stop serving.

00:29:36.660 --> 00:29:47.100
Evdokia Korakianiti-EMA: Six months three active substance one finished product side and 15 called control sides it's variation was approved in less than less than seven days.

00:29:48.060 --> 00:29:58.230
Evdokia Korakianiti-EMA: In some cases even next and under normal circumstances, it, it would have taken, I was coverage 60 days timetable and with the clock stuff would have been.

00:29:58.710 --> 00:30:18.150
Evdokia Korakianiti-EMA: An average of three months anything inspection needed, which was one of the cases and we'd be more around five to six months to conduct social and corporate inspection, so I believe you can see the rabbit approval that we have a teeth a using these flexibly this next slide please.

00:30:24.030 --> 00:30:24.480
Evdokia Korakianiti-EMA: Thank you.

00:30:27.060 --> 00:30:38.970
Evdokia Korakianiti-EMA: I hope this illustrates that a number of alternative approaches have been used to facilitate timely approval and oxygen patients to have covered vaccines, but of course.

00:30:39.510 --> 00:30:50.010
Evdokia Korakianiti-EMA: extend those flexibilities are subject to the products that process, knowledge and decide readiness and in this particular case, it was a very, very good example of extensive.

00:30:50.820 --> 00:30:58.320
Evdokia Korakianiti-EMA: Experience that was available that allow to mitigate that second is from the end of the data packets that was available it's a time of approval.

00:30:59.760 --> 00:31:08.490
Evdokia Korakianiti-EMA: different assessments to verify simply compliance in a very useful supporting tools in terms of the content and.

00:31:10.380 --> 00:31:11.850
Evdokia Korakianiti-EMA: Needless to say, that.

00:31:12.960 --> 00:31:23.160
Evdokia Korakianiti-EMA: The a and responded frequent interactions regulators was highly recommended and made possible to get alignment on data packages timelines privatization of changes.

00:31:24.570 --> 00:31:28.980
Evdokia Korakianiti-EMA: The status is reviews and the decent assessment require a lot of additional coordination.

00:31:29.670 --> 00:31:41.220
Evdokia Korakianiti-EMA: required assessors to 10 of our assessments in a very limited time lines and, of course, put a lot of stress to the network and, in our experience very good interactions the applicant.

00:31:41.820 --> 00:31:56.910
Evdokia Korakianiti-EMA: To clear prioritize changes post approval based or shown a impact on supply or alien identify potential and need 14 peace patience to ensure that we organize that this assets have been a key have been key to.

00:31:57.930 --> 00:31:59.700
Evdokia Korakianiti-EMA: Success next leg.

00:32:05.070 --> 00:32:20.100
Evdokia Korakianiti-EMA: it's important to highlight that is poor and that we're discussing about flexibilities However we on this flexibility is by no means to them, represent a reduction, the standard they started remember saying what think this is a time, you have the data submission.

00:32:21.750 --> 00:32:31.410
Evdokia Korakianiti-EMA: And that's why we keep saying that it later on a key one of the key enablers of a lot of flexibility, this is the available data pockets, the more.

00:32:32.070 --> 00:32:41.970
Evdokia Korakianiti-EMA: Product process knowledge is available, the more ready, the side as a, both in terms of manufacturing experience but also potential to be the.

00:32:42.450 --> 00:32:48.930
Evdokia Korakianiti-EMA: The more the better than sentences from the limited data packets can be mitigated through.

00:32:49.470 --> 00:33:06.750
Evdokia Korakianiti-EMA: They have a good characterization and cons control strategy very good pro product, the product and process understanding, a new see later on an example of what platform a protest and like that we can ensure that the benefit risk is stay positive despite.

00:33:09.480 --> 00:33:14.130
Evdokia Korakianiti-EMA: The different timelines in completing the food other pockets next leg.

00:33:19.830 --> 00:33:20.730
Evdokia Korakianiti-EMA: Next slide please.

00:33:24.390 --> 00:33:34.260
Evdokia Korakianiti-EMA: Thank you, we look forward to this workshop, and we look forward to this interaction and to understand better out of all the senses, that we have introduced what has worked well.

00:33:34.680 --> 00:33:47.580
Evdokia Korakianiti-EMA: What has been the most useful and in which cases and what has been the least effective and also with a view to the future, where the changes that we should be working on, we should be working on, as a matter of priorities.

00:33:48.780 --> 00:34:02.490
Evdokia Korakianiti-EMA: Thank you to account that we are still in the midst of the pandemic and what does it made a tentative for seeing from industry over the next 12 months and what does a lot of bottlenecks, we need to address as a matter of priority next slide.

00:34:06.570 --> 00:34:21.720
Evdokia Korakianiti-EMA: Thank you, I said conclusion the seven shows that the regulators globally have responded rapidly to enable a timely access to places of college boxing's and a number of flexibility, have been used.

00:34:23.010 --> 00:34:25.170
Evdokia Korakianiti-EMA: To make the regulatory environment even more time.

00:34:26.340 --> 00:34:39.600
Evdokia Korakianiti-EMA: And the example demonstrated, some of these take into account, of course, the global element of supply and also Australia highlighted in the survey, they still are still opportunities for further collaboration convergence.

00:34:40.440 --> 00:34:47.640
Evdokia Korakianiti-EMA: between regulators, that will allow us to become even more efficient in addressing global public health.

00:34:48.720 --> 00:34:55.260
Evdokia Korakianiti-EMA: needs in the future, and I really hope that this will submit a step towards this direction, thank you very much for my side.

00:34:58.020 --> 00:35:05.880
Emer Cooke: Thank you very much Sean Thank you very much, you have Doc here excellent overview of what the regulators have done, and some of the.

00:35:06.720 --> 00:35:12.690
Emer Cooke: Some of the experiences that we have from the regulatory side, I think it really provides.

00:35:13.380 --> 00:35:31.080
Emer Cooke: A platform to move over to the industry experience, and I would like to hand over to Connie longer who's going to talk about the perspective of industry on the scientific and with beta protest to enabling rapid increase manufacturing capacity so over to you call me please.

00:35:31.920 --> 00:35:35.880
Connie Langer: Thank you and good morning good afternoon and good evening.

00:35:36.960 --> 00:35:47.700
Connie Langer: I am a regulatory strategist and the global cmc group at Pfizer and i'm really grateful for the opportunity to be here with you today and i'm pleased to present this topic on science and risk based approaches.

00:35:48.060 --> 00:35:52.710
Connie Langer: To enable the rapid increase in manufacturing capacity for therapeutics and vaccines.

00:35:53.220 --> 00:36:00.090
Connie Langer: And this is on the collective behalf of industry associations that jointly organize this workshop with ICM ra.

00:36:00.540 --> 00:36:07.380
Connie Langer: So in this session I plan to provide an overview of the challenges that hinder manufacturers ability to increase capacity.

00:36:07.920 --> 00:36:18.630
Connie Langer: And to identify priority regulatory mechanisms and flexible cmc approaches that industry views is critical to success of rapidly increasing manufacturing capacity.

00:36:19.320 --> 00:36:35.580
Connie Langer: And to present recommendations on science and risk based approaches that should be utilized to enable rapid increases in manufacturing capacity and to mitigate drug shortages and facilitate timely patient access to quality medicines and vaccines next slide please.

00:36:39.840 --> 00:36:40.650
Connie Langer: Next slide please.

00:36:43.500 --> 00:37:01.740
Connie Langer: Thank you, given the threat to the Global Health, we need to proactively address the quality of regulatory aspects associated with rapid the providing billions of doses of new medicines and vaccines to save lives, this is really an unprecedented challenge and it requires new thinking.

00:37:03.240 --> 00:37:19.020
Connie Langer: has had an impact on all sectors of supply chain spanning from raw material suppliers to manufacturers wholesalers and distributors, this has created a greater need for regulatory agility to enable increase manufacturing capacity next slide please.

00:37:21.840 --> 00:37:32.130
Connie Langer: So key strategies to increase manufacturing capacity include both addition of manufacturing sites for the new product as well as moving existing products to alternate sites.

00:37:32.640 --> 00:37:45.390
Connie Langer: So global variability in data requirements and time to regulatory approval in cmc variations can result in supply shortages, as well as delay patient access to quality MAC vaccines and medicines.

00:37:46.410 --> 00:37:57.240
Connie Langer: Typical data package needs to justify a change from one site to another or to add a manufacturing facility includes process validation analytical method validation at the new site.

00:37:57.780 --> 00:38:05.070
Connie Langer: Real time stability studies with varying amounts of data need at the time submission and product comparability testing.

00:38:05.400 --> 00:38:14.640
Connie Langer: companies that operate on a global scale are challenged by the complexity caused by very upfront documentation, for example, you might need three months of data.

00:38:15.510 --> 00:38:27.990
Connie Langer: For some markets and up to 12 months of real time data for other markets, you might also need multi point to solution in some markets and maybe even obesity and other markets next slide please.

00:38:32.700 --> 00:38:52.440
Connie Langer: So a major challenge with post approval site changes is that customized dossiers are often prepared for each individual market, and this is because not only the requirements for specific changes differ across markets, but also, and perhaps just as important, the requirements.

00:38:54.210 --> 00:39:04.050
Connie Langer: And customization are needed for those markets so a range of data requirements, as well as differences interpretation of ic H guidelines have been observed.

00:39:04.350 --> 00:39:08.670
Connie Langer: These differences are generally not tied to patient safety or therapeutic needs.

00:39:09.030 --> 00:39:21.120
Connie Langer: Patients would benefit if industry and regulators could work together to eliminate country specific control strategy differences to enable pharmaceutical manufacturing processes to become really truly global.

00:39:22.740 --> 00:39:35.910
Connie Langer: So varying the regulatory review times are also a challenge in terms of planning supply strategy, for example, it could take four months to review a supplement in one market and, as we just heard.

00:39:36.540 --> 00:39:40.230
Connie Langer: In the previous presentation those timelines have been shortened during this pandemic.

00:39:40.710 --> 00:39:49.140
Connie Langer: But there's still a variation and in normal times, it could take several years to approve that same variation in other markets.

00:39:49.410 --> 00:40:01.680
Connie Langer: So the manufacturer, then, must do extensive planning to ensure adequate supply is available prior to transferring product to avoid shortages or stock outs of an existing medicine next slide please.

00:40:04.470 --> 00:40:16.950
Connie Langer: So this slide shows the variability of query volume for initial registration of several different Pfizer products, so these are new chemical entities biologics vaccines, not the covert vaccine and this example.

00:40:17.400 --> 00:40:25.230
Connie Langer: And also combination products so each individual product dossier contain the same control strategy as a starting point.

00:40:25.950 --> 00:40:34.200
Connie Langer: And if you look across the first row, for example, nc one you'll see the total number of questions raised by different global sorts of health, ranging from.

00:40:34.620 --> 00:40:46.980
Connie Langer: In most part, around 15 to about 55 questions so that represents a three fold difference depending on authority and the column for the EU displays the number of draft questions raised at at.

00:40:47.280 --> 00:40:53.790
Connie Langer: Of the procedure and you'll notice that there's a difference in volume for for the rapper tour versus the Co rapid tour.

00:40:54.870 --> 00:41:04.950
Connie Langer: In this data set, it was noted that the official day 120 queries included a lump sum of these questions without really a reduction in unnecessary or redundant questions.

00:41:05.460 --> 00:41:19.920
Connie Langer: And this data sets not unique to Pfizer and an aggregated set has been presented with detailed analysis of the impact of control strategy at a recent IQ consortium webinar on control strategy harmonization that was held Justice last May.

00:41:20.790 --> 00:41:29.010
Connie Langer: The trends indicate that less than 20% of the questions from the different forms of health are the same and highlights clear differences in interpretation of ic h.

00:41:29.460 --> 00:41:33.270
Connie Langer: and results in differences and approved control strategy for global products.

00:41:33.750 --> 00:41:52.500
Connie Langer: So while this table is for initial market authorization application, the query trends are similar for post approval supplements and variations and we've just included this as an illustrative example of the volume and variability of queries received across regions next slide please.

00:41:55.680 --> 00:42:05.970
Connie Langer: An additional challenge is a pre approval inspections for site changes or additions pre approval inspections are often needed but conducting on state onsite PA is.

00:42:06.420 --> 00:42:17.460
Connie Langer: has been extremely challenging during coven 19 due to pandemic related travel restrictions as a result, the regulators have turned to several different alternative tools to assess the manufacturing facilities.

00:42:17.760 --> 00:42:26.100
Connie Langer: Either virtually or remotely including but not limited to record request remote desktop assessments and virtual inspections.

00:42:27.150 --> 00:42:35.970
Connie Langer: it's important to note that the specific tools used the terminologies used to describe them and the extent to which the given tools utilized by.

00:42:36.930 --> 00:42:50.280
Connie Langer: each region is very because a universal toolbox of alternate tools to success regional differences may limit reliance practices at a time when increased reliance is critically needed next slide please.

00:42:53.850 --> 00:43:07.620
Connie Langer: So, while the focus of this presentation is on the regulatory challenges related to post approval site transfers, we do want to ensure it's understood that there are additional challenges that hinder manufacturers abilities to rapidly increase manufacturing capacity.

00:43:08.100 --> 00:43:13.290
Connie Langer: we're not going to discuss all of the additional challenges in detail today i'll touch on a few.

00:43:13.980 --> 00:43:22.500
Connie Langer: So we faced significant challenges with raw material supply constraints, in particular, with a supply of limits for the Mr and a vaccines.

00:43:22.980 --> 00:43:31.800
Connie Langer: The supplier, so these materials were really just accustomed to supplying a small scale for development purposes and didn't have experienced with commercial supply.

00:43:32.430 --> 00:43:47.940
Connie Langer: The rapid large scale demand those challenges that required qualification of additional suppliers, which leads to the next two bullets on the list so it's expedited qualification for those new suppliers for both lipids and other materials like Product Contact filters.

00:43:48.960 --> 00:43:55.890
Connie Langer: And to meet that higher demand both the suppliers of those raw materials, as well as the innovative companies face challenges to meet.

00:43:56.220 --> 00:44:07.530
Connie Langer: The workforce demands, so all of these issues listed here are important to keep in mind as they can have a substantial impact on the ability to rapidly increase manufacturing capacity.

00:44:08.640 --> 00:44:09.570
Connie Langer: Next slide please.

00:44:13.650 --> 00:44:20.670
Connie Langer: So, in preparation for the workshop regulators asked industry to complete a questionnaire to identify key regulatory mechanism.

00:44:20.820 --> 00:44:33.930
Connie Langer: and flexible cmc approaches that industry believes are critical to success, a rapidly increasing manufacturing capacity for Cobra therapeutics and vaccines this slide describes industry's top priorities from the questionnaire.

00:44:35.100 --> 00:44:50.190
Connie Langer: First establishment of quick frequent and continuous communication is widely cited as being particularly important and the utility of these communications is optimized when the regulator's engaging with the manufacturers have decision decision making authority.

00:44:51.630 --> 00:45:00.210
Connie Langer: full or partial reliance on assessment reports of regulatory authorities from other regions can reduce the complexity associated with lifecycle management.

00:45:01.980 --> 00:45:11.580
Connie Langer: Third, acceptance of alternate process qualification validation approaches such as concurrent validation decoupling drug substance into our product validation.

00:45:12.000 --> 00:45:22.500
Connie Langer: and continuous process validation are important and forth the approval of post approval changes in the absence of full data, this is particularly useful.

00:45:22.770 --> 00:45:38.760
Connie Langer: For activities with long lead times like stability testing and process validation as the ability to provide this data at a later date can result in substantially faster development timelines as well as enable expedited regulatory approvals next slide please.

00:45:41.850 --> 00:45:55.290
Connie Langer: So as i've outlined in the previous slides ensuring regulatory compliance in multiple regions, while rapidly expanding supply chain to meet global demand at an unprecedented scale presents a multitude of challenges that must be addressed.

00:45:55.920 --> 00:45:58.740
Connie Langer: Consistent with results from the questionnaire that I just described.

00:45:59.520 --> 00:46:12.240
Connie Langer: Industry has identified a set of key recommendations to national regulatory authorities that industry believes, if implemented, will enable the rapid increase in manufacturing capacity for covert therapeutics and vaccines.

00:46:13.020 --> 00:46:20.520
Connie Langer: So those key recommendations fall into four categories, starting with streamline stability testing requirements.

00:46:21.150 --> 00:46:34.350
Connie Langer: Many countries are many changes require a standard two to three batches and some level of three to six month accelerated stability data and up to 12 months of real time data for some countries.

00:46:35.130 --> 00:46:41.520
Connie Langer: The flexibility requirements is needed, and we encourage acceptance of predictive stability tools to set provisional shelf life.

00:46:42.180 --> 00:46:52.170
Connie Langer: While long term stays progress and focus the value of available registration data, rather than the additional confirmatory data sets that can add years to the filing timelines.

00:46:53.250 --> 00:46:59.700
Connie Langer: Industry second key recommendation is for regulators to embrace alternate process validation approaches.

00:47:00.060 --> 00:47:11.130
Connie Langer: During the pandemic approaches that leveraged reduce data package, based on risk platform data and prior knowledge concurrent validation and decoupling drug substance to drug product validation.

00:47:11.940 --> 00:47:23.790
Connie Langer: And the continuous process verification were really extremely helpful in meeting the emergency medical need and industry, encourages the continuation of these practices next slide please.

00:47:26.910 --> 00:47:35.970
Connie Langer: So third an increase use and harmonization of approaches to inspection alternatives, it will be important for regulators to.

00:47:36.390 --> 00:47:44.010
Connie Langer: more widely adopted alternative tools such as virtual inspections and try to harmonize regional approaches, with respect to tool selection.

00:47:44.580 --> 00:47:57.630
Connie Langer: conduct and terminology in order to create additional resource efficiencies and better enable reliance practices at a time when regulators abilities to conduct on site inspections are severely limited.

00:47:58.170 --> 00:48:07.890
Connie Langer: A key part of this harmonization effort will be the sharing of best practices and lessons learned, as all stakeholders gain familiarity with the use of these alternate tools.

00:48:08.460 --> 00:48:12.330
Connie Langer: And finally, enhanced collaborative review and reliance practices.

00:48:12.900 --> 00:48:24.090
Connie Langer: Rapid global access to important medicine means simultaneous submission, however, industry resources can't handle global submissions all at once to address individual reaching concerns independently.

00:48:24.600 --> 00:48:36.390
Connie Langer: alignment on these requirements across markets is essential to remove unnecessary individual requirements and strategy should be used to enable efficient regulatory review and harmonization of content and format.

00:48:36.900 --> 00:48:48.000
Connie Langer: So some of those recommendations include expanding the violence practices to include both regulatory review pre approval inspections and alternate tools to assess manufacturing facilities.

00:48:49.140 --> 00:49:00.090
Connie Langer: global harmonization of regulatory requirements and adherence to ic H and reliance practices collaborative review that form the basis of global review acceptance.

00:49:00.540 --> 00:49:09.540
Connie Langer: and reducing the need for redundant import and release testing so Taken together, these recommendations would expedite global submissions and approvals.

00:49:09.810 --> 00:49:23.790
Connie Langer: relieve the burden of maintaining multiple versions of quality related documentation reduce cost of maintenance and ultimately allow faster delivery of quality medicine to and vaccines to patients next slide please.

00:49:26.850 --> 00:49:40.260
Connie Langer: So the coven 19 pandemic has made it unequivocably clear that diverging global regulatory requirements constraints supply chains and can delay patient access to needed medicine and vaccines.

00:49:41.100 --> 00:49:48.330
Connie Langer: Industry and regulators can and must work together to create a world where patients have access to high quality medicines and vaccines.

00:49:48.750 --> 00:49:59.190
Connie Langer: They need a timely and efficient manner, and I want to thank you all for your attention, as well as thank you, I see Mr Ray for the opportunity to present today on behalf of my industry colleagues.

00:50:01.140 --> 00:50:17.190
Emer Cooke: Thank you very much Connie excellent presentation excellent overview of some of the challenges that you have seen and but some of the some of the opportunities that industry see in the in this in this context.

00:50:18.240 --> 00:50:25.800
Emer Cooke: we're running a little bit late, I have to confess part of this is because, as a moderator I haven't figured out how to.

00:50:29.100 --> 00:50:38.790
Emer Cooke: encourage people to move move along and I, and I wasn't sure how many slides people have in their Park, so we are a little bit over time.

00:50:39.570 --> 00:50:50.670
Emer Cooke: But we have a couple, I think we have time for a couple of questions here and hopefully we'll be able to make up the time later, so let me just start immediately.

00:50:51.300 --> 00:51:14.340
Emer Cooke: With a question from for our panel members, the panel members or Sean abductee and Connie who just presented, and let me just ask Sean, whether from the regulatory side, whether any results of the industry questionnaire were for surprising and, if so, what what show and.

00:51:14.910 --> 00:51:19.710
Sean Barry: I would say no, not not really I mean I think it's in line with what we would have expected.

00:51:20.100 --> 00:51:26.850
Sean Barry: I mean, for me it kind of represents a general desire from industry, which has been put forward over the last few years and, indeed, a lot of these issues.

00:51:27.450 --> 00:51:31.980
Sean Barry: have been discussed in in many interactions with the industry over the last couple of years and workshops and so.

00:51:32.610 --> 00:51:42.570
Sean Barry: So I mean if we were to look at the top three in particular was the number one or number two that got the number one spot and the most frequently ranks number one was.

00:51:43.140 --> 00:51:48.810
Sean Barry: The communication aspect and frequent communication this, as I said, it's been a key aspect that particular for the covert products and.

00:51:49.890 --> 00:51:56.760
Sean Barry: It seems that industry must have found this useful because it's been ranked number one and it's very important, particularly in terms of increasing manufacturing that we have.

00:51:57.360 --> 00:52:06.720
Sean Barry: foresight of what's coming down the line, particular type of timeline plan for gold industry and regulators and to allocate resources appropriately, so that we can.

00:52:07.830 --> 00:52:13.500
Sean Barry: You know, introduce these changes as quickly as possible so communication is key, so that doesn't surprise me that that's there.

00:52:14.010 --> 00:52:27.060
Sean Barry: Also, the reliance again and it's an important aspect in terms of maybe relying on other regulators assessments again, this may be challenging for legal reasons, and so on, but certainly in terms of.

00:52:30.120 --> 00:52:37.200
Sean Barry: adding more this definitely scope for collaborative assessment of our projects like project orbison between FDA tj and health, Canada and.

00:52:37.470 --> 00:52:43.680
Sean Barry: The open initiative, where other regions can take part in, you may assessments so he's talking burning projects are very important for that.

00:52:44.160 --> 00:52:49.110
Sean Barry: That goal and that there are international clusters for vaccines and 18 pieces so on that fulfillment.

00:52:50.040 --> 00:53:06.000
Sean Barry: And me personally i'd like to see these projects piloted maybe enhance collaboration between agencies and both from the regular assignment from industry, I mean it doesn't involve input from industry in terms of sharing reports and unproductive assessment ports and so on.

00:53:06.570 --> 00:53:09.810
Sean Barry: You know, we can you can look to the future and look at certain aspects that can.

00:53:10.650 --> 00:53:21.450
Sean Barry: Particularly be of use like maybe global post approval change management protocols or so on we're industry get one list of questions, I mean just quickly the second to then two and three was.

00:53:23.220 --> 00:53:31.470
Sean Barry: The supplier Knowledge Platform platform approaches again not surprising, we have seen much more use of personality recently and alternative platform.

00:53:31.950 --> 00:53:44.640
Sean Barry: approaches were much more familiar with current validation indeed it's worked well in it for vaccines uncover products and take him to work well for the products and and it has been implemented and the final one that I think was.

00:53:46.050 --> 00:53:49.440
Sean Barry: approved with changes in the options of the full data package and again.

00:53:50.100 --> 00:53:53.010
Sean Barry: As I said, maybe philosophical change where it's it's.

00:53:53.250 --> 00:54:03.930
Sean Barry: we're more comfortable now with the procedures in place for proving either a new product or variation where we don't have all the data we normally would have and we have structures in place around that data will be provided.

00:54:04.920 --> 00:54:11.490
Sean Barry: Later on, and as a document pointed out it's not a reduction in requirements it's a change of when the full data package will be available so.

00:54:13.020 --> 00:54:21.690
Sean Barry: For those three points so fully agree with industry and so, for that reason I wouldn't particularly see them has been surprising and the things that we're working on thanks.

00:54:22.590 --> 00:54:27.210
Emer Cooke: Thank you very much Sean and Connie if I could ask the same question to you.

00:54:28.530 --> 00:54:30.000
Emer Cooke: Do you did you from the.

00:54:31.680 --> 00:54:37.680
Emer Cooke: survey that we did, did you see anything surprising from the results of the regulator's questionnaire.

00:54:39.060 --> 00:54:51.270
Connie Langer: I think I think we're actually quite aligned with what Sean just mentioned, and I think the key things came out of that were not surprising, but maybe one thing that was a little bit surprising is that.

00:54:52.260 --> 00:55:03.450
Connie Langer: The regulatory side issued public guidance, is to clarify regulatory expectations on how assessment of these critical drugs or biologics would be prioritized in the pandemic.

00:55:03.870 --> 00:55:11.490
Connie Langer: And I guess, I was surprised to see that ranks relatively low, I think that those are probably really important but.

00:55:12.000 --> 00:55:22.380
Connie Langer: What was even more important during this pandemic was the discussions and conversations that have already been mentioned, between industry and regulatory on.

00:55:23.130 --> 00:55:35.970
Connie Langer: The important vaccines and therapeutics those those conversations have been incredibly important and useful, and we really appreciate the collaboration and guidance provided by the regulatory authorities.

00:55:37.500 --> 00:55:45.600
Emer Cooke: Thank you very much Connie and in fact I think this is one of the key messages coming out the importance of the collaboration.

00:55:46.800 --> 00:55:55.980
Emer Cooke: Communication and really agile communication, which was a feature it continues to be a feature of of this.

00:55:57.090 --> 00:56:03.300
Emer Cooke: Of the interactions and F dokey, what do you think will be.

00:56:04.530 --> 00:56:08.280
Emer Cooke: have been the most challenging flexibilities to introduce.

00:56:11.790 --> 00:56:27.540
Evdokia Korakianiti-EMA: me man, I cannot comment on flexible on their own, because flexibilities go hand in hand with the data that's available so as demonstrated interest sluggish ratings and slider presented, he said, other boxes stronger than.

00:56:28.560 --> 00:56:40.170
Evdokia Korakianiti-EMA: The research around the data sets in this and incomplete data packets can be mitigated easier stepping back, of course, one can say that.

00:56:41.400 --> 00:56:48.990
Evdokia Korakianiti-EMA: Although we have used flexibility when it comes to compatibility for support team is accepting your site, without any compatibility data.

00:56:50.310 --> 00:57:09.330
Evdokia Korakianiti-EMA: It is rather challenging also sorts of sites in countries that are difficult to reach without any tmp history by any of the partners like a in certain countries again requires additional coordination with the current yankovic is an additional problem.

00:57:11.100 --> 00:57:13.230
Evdokia Korakianiti-EMA: it's not a talent per se but.

00:57:14.430 --> 00:57:31.410
Evdokia Korakianiti-EMA: The saying of assessment board post approval and interaction with our international partners when we are doing expected assessments within a couple of days is a huge talent, but it is covered by the fact we have been extensively interacting it's a pre approval states.

00:57:33.450 --> 00:57:44.580
Evdokia Korakianiti-EMA: So all you know I think the biggest challenge has been the time constraint and there's trying to the network and to make all this happen, thank you.

00:57:45.600 --> 00:57:51.810
Emer Cooke: Thank you very much of Doc here and i'm just realizing that I have been.

00:57:52.860 --> 00:58:03.690
Emer Cooke: very lucky in that I did I meant to be co moderating this with three the Teresa is there anything that you would like to add to raise at this point.

00:58:04.950 --> 00:58:21.420
Theresa Mullin: Thank you, thank you, you know, I think, in the interest of time, as you were pointing out before, perhaps we should just proceed to the case studies and and go from there, so we can get as much panel, and you know we don't lose content later so but thank you okay.

00:58:22.200 --> 00:58:33.480
Emer Cooke: Thank you very much Theresa and just to say that we now have over 330 people online there's also a possibility to put questions in the Q amp a.

00:58:33.870 --> 00:58:46.650
Emer Cooke: And these can be addressed by panelists later in the in the session, but in the interested in time, I would take phrases advice and move immediately on to the regulators case studies.

00:58:47.070 --> 00:58:59.190
Emer Cooke: And our first one is from FDA and take era arlen's and I think it stelios this who was starting here now from FDA.

00:59:02.760 --> 00:59:12.600
Karl Cogan (HPRA): So fema just just a quick word i'm just going to help just my name is Carla cogan everybody so i'm just from the health products Regulatory Authority of Ireland so i'm just going to.

00:59:12.960 --> 00:59:21.870
Karl Cogan (HPRA): With regard to that case studies i'm very conscious of time as well, so i'm just going to help kind of shift these along so we're going to hear four different case studies and from from our.

00:59:22.140 --> 00:59:29.010
Karl Cogan (HPRA): Regulatory colleagues and they're going to detail some of the experiences and approaches they've had with regard to the.

00:59:29.910 --> 00:59:35.670
Karl Cogan (HPRA): rapid increase in manufacturing and and the use of flexibility is to facilitate post approval changes.

00:59:36.210 --> 00:59:43.890
Karl Cogan (HPRA): So we've set our speakers like kind of a tough task they have three minutes to kind of detail some of the major challenges that they've experienced in addition to.

00:59:44.190 --> 00:59:47.040
Karl Cogan (HPRA): Some of the accomplishments and key achievements and learning so.

00:59:47.340 --> 00:59:54.780
Karl Cogan (HPRA): Just before we get started, I just want to thank all of the regulatory agencies that submitted a case 30 like it was it was absolutely fantastic response and.

00:59:55.020 --> 01:00:06.450
Karl Cogan (HPRA): somebody's information is very, very valuable and it's fed into the development of the discussions for this session and then also in day two as well, so thanks very much to everybody was it was absolutely fantastic.

01:00:07.020 --> 01:00:15.510
Karl Cogan (HPRA): So just with regard to tell him I we're just going to get and it's going to introduce stelios so stelios sanity, this is the director of office and.

01:00:15.840 --> 01:00:24.060
Karl Cogan (HPRA): Is director of the Office for pharmaceutical manufacturing assessment and with the US Food and Drug Administration and so stelios please over to you.

01:00:25.170 --> 01:00:42.090
Stelios Tsinontides, FDA: Thank you, Carl good morning everyone Good afternoon, good evening it's a great pleasure to be here and be able to present a case study on behalf of our teams here in old PQ of the FDA and if we can go to the next slide.

01:00:45.150 --> 01:00:55.740
Stelios Tsinontides, FDA: And then the next slide, this is a case study about a request for a technical transfer and we receive this request at the start of the pandemic.

01:00:56.460 --> 01:01:03.600
Stelios Tsinontides, FDA: Around the second quarter of last year and basically the sponsor approached us with a request.

01:01:03.930 --> 01:01:19.830
Stelios Tsinontides, FDA: To or for a site changes for several of their commercial products and, in this case, he was Brock substances biologic drug substance says to create capacity for the development and manufacture of coffee therapeutics.

01:01:20.430 --> 01:01:41.430
Stelios Tsinontides, FDA: The sponsor requested a Type C meeting to cover as I noted multiple products with a rapid turnaround, as you can imagine the urgency of the request and the pressure during the early months of the pandemic pandemic were high So how do we engage with the sponsor right away.

01:01:42.570 --> 01:01:56.100
Stelios Tsinontides, FDA: After they contacted us within a week we held a meeting with them to understand fully their request and during the period of our engagement with them i'm.

01:01:56.820 --> 01:02:12.150
Stelios Tsinontides, FDA: The keep timeframe that we're standing weekly meetings with a sponsor and relevant people from both the our agency, and also the sponsor to discuss the related submissions.

01:02:12.630 --> 01:02:25.920
Stelios Tsinontides, FDA: The sponsor provided a timeline of plans submissions and requested assessment dates based on demonstrated supply needs, he was very, very important that we understand.

01:02:26.250 --> 01:02:35.910
Stelios Tsinontides, FDA: The supply situation and make sure that the scope of this mission focused on the immediate supply needs.

01:02:36.870 --> 01:02:44.160
Stelios Tsinontides, FDA: What were some of the challenges and accomplishments during that engagement, obviously, as I noted earlier.

01:02:44.880 --> 01:03:00.090
Stelios Tsinontides, FDA: There was a need for an expedited assessment and the level of engagement and effort was very resource incentive, as noted also earlier by our other regulatory colleagues for such cases.

01:03:01.980 --> 01:03:05.160
Stelios Tsinontides, FDA: A we applied and we allowed.

01:03:06.210 --> 01:03:12.420
Stelios Tsinontides, FDA: Some concurrent validation and, in some cases upon reviewing the information.

01:03:12.810 --> 01:03:27.300
Stelios Tsinontides, FDA: And we caught available and was submitted by the sponsor we allowed the downgrading of some of the supplements, so that we would allow them the authorization or the the.

01:03:28.260 --> 01:03:42.120
Stelios Tsinontides, FDA: authorization and approval we also made use of the 704 a four tool to for record requests for multiple of the manufacturing suites that they were involved with the submission.

01:03:42.810 --> 01:04:00.030
Stelios Tsinontides, FDA: And what we were able to do is to approve seeks priya priya supplements and also do so we think less than 35 days from contacting us with these requests.

01:04:00.510 --> 01:04:13.050
Stelios Tsinontides, FDA: At the same time, I have to say that we were able to do that because we had some level of confidence on their manufacturing side that he was involved with this tech transfer.

01:04:13.350 --> 01:04:20.220
Stelios Tsinontides, FDA: Even though we did not have any information or prior information on the particular manufacturing.

01:04:20.640 --> 01:04:31.980
Stelios Tsinontides, FDA: suites that they were involved, so we were able to get agreement that we would do an inspection to verify our seven or four a for conclusions.

01:04:32.700 --> 01:04:45.660
Stelios Tsinontides, FDA: So what are some of the learnings and recommendations, based on that engagement, the clarity on the detail and the format of the supply chain needs were absolutely necessary.

01:04:46.830 --> 01:05:01.020
Stelios Tsinontides, FDA: We we wanted to make sure that we focused on the immediate supply needs, so the sponsor was able to provide us, they are immediate needs and justify that.

01:05:01.680 --> 01:05:11.250
Stelios Tsinontides, FDA: The clarity of the detail necessary for for the expediting assessment and the approach to prioritize the request again.

01:05:11.610 --> 01:05:23.130
Stelios Tsinontides, FDA: To based on the public health impact is these level of effort would not be sustained sustainable across a large number of products and requests.

01:05:23.610 --> 01:05:37.500
Stelios Tsinontides, FDA: And we utilize this approach for additional call good 19th or petty request by sponsors to expedite the request that is requesting them.

01:05:38.280 --> 01:06:01.170
Stelios Tsinontides, FDA: A very detail supply need and again making sure that we focus on the immediate needs, and not on the longer term needs, in fact, we scale down in some of those reviews just to make sure that we address the immediate public health needs and with these I pass back to you, Carl.

01:06:01.890 --> 01:06:10.140
Karl Cogan (HPRA): Thanks very much Sally oh so we'll get on to the next presentation, so this is from Dr Raphael Sanchez Pereira from and visa so Raphael, please over to you.

01:06:11.610 --> 01:06:17.250
Raphael Pereira: Thank you, thank you for the for the opportunity for the time to present here, I will be.

01:06:18.600 --> 01:06:23.820
Raphael Pereira: very quick, because we have short time, so please move on to the next slide.

01:06:25.080 --> 01:06:43.500
Raphael Pereira: My case study the case study that Brock here is not related to a biological but it's small molecule it's quite representative of the challenges that we have during this pandemic it's an ODI related product so it's it's cool with related to not.

01:06:44.580 --> 01:06:57.060
Raphael Pereira: Go with a therapeutic it's important for to maintain the patients this kind of product had very high increase during the pandemic in Brazil and.

01:06:57.750 --> 01:07:13.230
Raphael Pereira: In most of countries we had our 10 times increase in five months and we had many problems in the service of the api's and at this specific case of the packaging material.

01:07:14.040 --> 01:07:24.870
Raphael Pereira: amber glasses for a short time were not available in this specific product was approved with in amber glasses, so we had.

01:07:25.950 --> 01:07:32.040
Raphael Pereira: To discuss an immediate change from Mr glass to transparent bless.

01:07:33.150 --> 01:07:38.970
Raphael Pereira: In order to avoid the product shortage because of the high demand and because of the.

01:07:39.810 --> 01:07:51.210
Raphael Pereira: increase because of the lack of amber glasses, so the product in this case is relatively photo lately so it's not really it's not very.

01:07:51.540 --> 01:08:02.400
Raphael Pereira: photo unstable but it's It shows some sensibility to light that's why it's in transparent bios the presentations that the boxes have.

01:08:02.910 --> 01:08:18.720
Raphael Pereira: had too many vials so we saw we use it to consider it as a risk, because the vials need to be taken off the boxes and so it's hard to trust the boxes for for to stability.

01:08:20.010 --> 01:08:32.520
Raphael Pereira: But we needed to understand this specific case very carefully, because the this case, we were talking about either a shortage of an important product at this time or.

01:08:34.320 --> 01:08:39.600
Raphael Pereira: risk for for the product quality, so we discuss it with sponsor.

01:08:40.650 --> 01:08:50.880
Raphael Pereira: To understand better the mechanism for the degradation, it was very important here, as well as in other post approval changes the previous knowledge, we had.

01:08:51.510 --> 01:09:03.060
Raphael Pereira: To we needed more flexibility on regular evidence is for post approval changes, for instance, we had to discuss ASAP stability protocols not.

01:09:03.780 --> 01:09:21.360
Raphael Pereira: Common real time stability data, we also have to discuss a more flexible photo stability study more related to quick exposure to photo stability we also discussed that with sponsor.

01:09:21.960 --> 01:09:33.270
Raphael Pereira: More specifically, being alert and due to the change in the packaging material, we also need to discuss a reduction in shelf life so that was.

01:09:34.590 --> 01:09:48.360
Raphael Pereira: Something that we had to discuss with sponsor in order to avoid higher risk, but the important learnings that we had not only from this specific case, but from other.

01:09:48.870 --> 01:10:11.160
Raphael Pereira: We had over 300 covert related posts approval changes only for small molecules not accounting for biologicals we learned that supporting data and previous knowledge always leverage is flexibility on both approval changes so was approval changes are.

01:10:12.390 --> 01:10:23.400
Raphael Pereira: difficult to treat as a general manner so it's difficult to understand a to to say exactly what will be needed for each post approval change.

01:10:24.510 --> 01:10:31.800
Raphael Pereira: And we understand that reveals knowledge is very important to leverage the flexibility at this case.

01:10:32.970 --> 01:10:40.380
Raphael Pereira: We understand also that we learned that that's something that we already knew, but it was very evident during the pandemic.

01:10:40.770 --> 01:10:48.720
Raphael Pereira: The dependence of one supplier, for instance, an API supplier incipient supply or in this case packaging material supplier.

01:10:49.500 --> 01:10:59.970
Raphael Pereira: represents an important risk, as well as the risk of the change, but the dependence itself of one single supplier is.

01:11:00.360 --> 01:11:08.040
Raphael Pereira: Very important we scan it's something that should be avoided by companies and also, I believe it should be.

01:11:08.400 --> 01:11:20.850
Raphael Pereira: better handled by the agencies in the in in the point that was approval changes should be taught, not only as demands as work, but as opportunities for instance.

01:11:21.420 --> 01:11:38.520
Raphael Pereira: increase an API supplier it's an important change to avoid the dependency of one supplier, as well as an approval, with different API product manufacturing sites it's important to avoid the dependency, which is very.

01:11:41.160 --> 01:12:02.250
Raphael Pereira: it's a it's a high risk for for the shark page, and we also understand that flexibility in post approval changes, not only for biologicals but also for small molecules it's an important measure for the health authorities it's difficult to treat post approval changes in a general manner.

01:12:03.330 --> 01:12:17.940
Raphael Pereira: it's difficult to have a checklist for them and flexibility base it on previous knowledge and on companies understanding of the product is very important for to avoid shortage in to avoid.

01:12:19.470 --> 01:12:21.810
Karl Cogan (HPRA): rough rough out, can I just just interrupt there so.

01:12:22.830 --> 01:12:27.810
Karl Cogan (HPRA): you'll have a chance to kind of extra kind of expand more during the panel discussion so we'll just.

01:12:28.110 --> 01:12:36.750
Karl Cogan (HPRA): Am just i'm just conscious of time, so we're already behind kind of schedule and little bit there, so if we could just go to the next slide please, and I just like.

01:12:37.320 --> 01:12:48.900
Karl Cogan (HPRA): I just like to introduce our next case study, so this is from Maria backup strategy so Dr rooms are Dr Australia and from from health Canada, so please take it away.

01:12:51.000 --> 01:13:02.310
Maria Baca-Estrada: Thank you, thank you for the invitation to participate, can I have the next slide please the case study, they are presenting on behalf of my colleagues hearing health Canada is the.

01:13:03.030 --> 01:13:14.160
Maria Baca-Estrada: The description is a vaccine, a new manufacturing brooks often facility, this amendment was submitted as as a part of the.

01:13:14.700 --> 01:13:24.450
Maria Baca-Estrada: Post approval chain to pro of the authorization of this product, and it was to address Canadian supply chain and vaccine delivery issues.

01:13:25.440 --> 01:13:41.250
Maria Baca-Estrada: The packet contain very limited information and the decision that lines of manufacturing concerns a rose contemporary honestly that means that there were issues happening at the time of when we're reviewing this package, however, as.

01:13:42.120 --> 01:13:58.500
Maria Baca-Estrada: Many of my colleagues have already expressed this was all of this was done in an expedited fashion the engagement with the sponsor was was key on this little Sam in a way, I look at transparency regarding critical manufacturing deviations.

01:13:59.550 --> 01:14:10.350
Maria Baca-Estrada: These deviations were only noted, as an Asterix without really any explanation in the file will learn the other major manufacturing concerns be a third party.

01:14:10.890 --> 01:14:18.210
Maria Baca-Estrada: And because we had to do this in such a short time we had to request, all of this information, as opposed to have summarization.

01:14:18.930 --> 01:14:29.850
Maria Baca-Estrada: The challenges and the accomplishments that we had with this package, it says he's been already discussed extremely tight timelines and very resource intensive.

01:14:30.540 --> 01:14:40.020
Maria Baca-Estrada: There was also an intersection between the regulatory decisions and the preset and the versus the perceived risk by the public, and this is something that.

01:14:40.380 --> 01:14:45.870
Maria Baca-Estrada: For to we don't have time right now to discuss, but it was a very important aspect, there was also.

01:14:46.410 --> 01:14:57.810
Maria Baca-Estrada: Different countries at that point had different benefit risk context due to some countries having a very, very short supply and very high disease prevalence so this also.

01:14:58.080 --> 01:15:07.770
Maria Baca-Estrada: is an important aspect that we have to take into account in situations of we are now the lack of harmonization, the product specification was also an issue in this review.

01:15:08.640 --> 01:15:18.660
Maria Baca-Estrada: And that also added additional time for us to do conduct evaluation, what are the learnings and their commendations I think they're very much in the same.

01:15:19.470 --> 01:15:27.150
Maria Baca-Estrada: points that have been raised so far, this morning the timely communication and transparency with the sponsor is key.

01:15:27.540 --> 01:15:35.610
Maria Baca-Estrada: The importance of communicating between all of us, the regulatory authorities, and this was highlighted by the lack of harmonization specifications.

01:15:36.450 --> 01:15:47.610
Maria Baca-Estrada: Their regulatory decisions that are really a national decision that should be done, based on the risk based in the benefit risk context and also the clarity.

01:15:48.840 --> 01:15:55.380
Maria Baca-Estrada: That it has to be defined on supply chain that would allow us to focus utilization of our resources.

01:15:56.460 --> 01:16:12.090
Maria Baca-Estrada: Rather than having 1020 different facilities narrowing down to facilities that will be supplying to our country, so I think this is, in a nutshell, what we had to face, and thank you again, we can discuss this, and thanks.

01:16:12.570 --> 01:16:19.080
Karl Cogan (HPRA): For your thanks very much that was that was an excellent presentation thanks a lot and just to move on to our final presentation so just wanted to.

01:16:19.320 --> 01:16:31.020
Karl Cogan (HPRA): Welcome back fdic here so Doc is going to talk a little bit about the European experience with regard to adding manufacturing and testing sites, in addition to manufacturing changes, so please document over to you.

01:16:33.450 --> 01:16:34.080
Evdokia Korakianiti-EMA: Thank you very much.

01:16:35.280 --> 01:16:41.760
Evdokia Korakianiti-EMA: So the talent you was robbing the addition of my function is of my function sides post approval.

01:16:43.620 --> 01:16:54.390
Evdokia Korakianiti-EMA: And this is a nice example away prior knowledge from other products using the same platform has been very, very useful to deliver ads.

01:16:56.160 --> 01:17:02.430
Evdokia Korakianiti-EMA: limitations inevitability of the other packages, so in this particular case, the applicant.

01:17:03.330 --> 01:17:14.760
Evdokia Korakianiti-EMA: be using the same platform for other vaccines, so there was a lot of information in regards to formulation process design control strategy and definitions of such life, obviously.

01:17:15.540 --> 01:17:34.230
Evdokia Korakianiti-EMA: The process validation process and the compatibility strategy was very well defined and discuss with regulators beforehand and another key enabler was the site readiness, because there was there was primary function experience with the same or similar products.

01:17:36.150 --> 01:17:48.090
Evdokia Korakianiti-EMA: The team, the compliance of this, it was already consider a timely flux and audiences with which is important for Europeans applied, but also time we identified.

01:17:48.540 --> 01:18:01.320
Evdokia Korakianiti-EMA: So, as it was a market validation we had all this prior knowledge in the dossier we had for process validation and bbq from three boxes plus three possibilities management protocols.

01:18:01.920 --> 01:18:13.590
Evdokia Korakianiti-EMA: So, in terms of engagement, we have been engaging very actively with the applicant through rapid scientific advisors for the preservation of the compatibility strategy.

01:18:15.000 --> 01:18:25.200
Evdokia Korakianiti-EMA: There have been only reviews of this cmc packages, as they became available facilitating then an accelerated time downloads for the market and cessation.

01:18:25.650 --> 01:18:41.340
Evdokia Korakianiti-EMA: And, but we used also a senior approaches, although they were not rolling reviews for the submission of data to support possible attentive so that are becoming available and assessed by the airport and.

01:18:43.230 --> 01:18:50.730
Evdokia Korakianiti-EMA: As they were becoming available, we have had regular interactions with our applicants a on the purpose of light same.

01:18:51.540 --> 01:18:57.660
Evdokia Korakianiti-EMA: Colleagues, Community and from the priests of nation states, before the marketing authorization was submitted.

01:18:58.020 --> 01:19:14.280
Evdokia Korakianiti-EMA: And then very actively for midway like this of questions onwards and very, very good collaboration, a to identify concrete supply, but also post approval with weekly touch points and interactions and, on top of me, using the exception of change management protocols that allow.

01:19:17.250 --> 01:19:25.170
Evdokia Korakianiti-EMA: exemptions have to see testing with any E and D temporary data transfer protocols are in place.

01:19:25.920 --> 01:19:38.070
Evdokia Korakianiti-EMA: So, as a result, the accomplishments within three months we had roughly the addition of a finished product sites within less than a week actually within a number few days compared to a minimum, started.

01:19:39.480 --> 01:19:42.150
Evdokia Korakianiti-EMA: longer than six days, I would say average three months.

01:19:43.260 --> 01:19:52.140
Evdokia Korakianiti-EMA: The site approvals based on day because of all this prior knowledge and also the compatibility data provided at some initial market authorization.

01:19:53.160 --> 01:20:02.430
Evdokia Korakianiti-EMA: For new sites approval was on the basis of a certificate of analysis from the fence bbq lot, and it was minus as a minor variation minor won't be variation.

01:20:02.760 --> 01:20:08.340
Evdokia Korakianiti-EMA: There is a data, I mean it was completed post a proven post them on the appropriate for the rest of the parties.

01:20:08.850 --> 01:20:15.300
Evdokia Korakianiti-EMA: And one of this resize to acquire the tmp inspection and with again under normal circumstances.

01:20:15.960 --> 01:20:30.000
Evdokia Korakianiti-EMA: Would the normal turnaround time would have been even longer than three months and we managed to complete the variation in such a short time frame, due to the at a very good interactions with the applicants to add vacations the site and the issue.

01:20:31.380 --> 01:20:34.050
Evdokia Korakianiti-EMA: Vegas collaboration with our international partners.

01:20:35.130 --> 01:20:44.580
Evdokia Korakianiti-EMA: And received the inspection report to support our model this an assessment, even though this the scope vaccines were not in the scope of them array.

01:20:45.090 --> 01:21:02.370
Evdokia Korakianiti-EMA: And another accomplishment was that in this toshi we included sites that were not intended for European supply but we're in order for the WHO cooks program and by adding them in not in the you don't see it allowed said countries to rely on are you a tmp certificates.

01:21:03.750 --> 01:21:07.440
Evdokia Korakianiti-EMA: The lens are quite similar to what with the rest of the regulator's.

01:21:09.120 --> 01:21:21.510
Evdokia Korakianiti-EMA: As I mentioned before paramount and flexibility skull candy hunt with and I leverage by the level of the product and process, knowledge and the state of readiness and in this particular case.

01:21:22.080 --> 01:21:32.310
Evdokia Korakianiti-EMA: They use the products from the platform technologies and mitigated a lot they're setting this around the data a limitation for for the addition of sites possible but.

01:21:33.810 --> 01:21:41.160
Evdokia Korakianiti-EMA: They have been a lot of interaction and interactions with the applicant from the sentence raw and post approval.

01:21:42.750 --> 01:21:53.160
Evdokia Korakianiti-EMA: That allowed also to address the complexity of a tmp aspects and, of course, as all other regulators this of course comes at a cost and.

01:21:53.880 --> 01:22:11.820
Evdokia Korakianiti-EMA: Always expected of us, and the recent assessments require put a strain to the network into the workload so again the need for a clear prioritization of the changes, based on the inputs on supply is neat and, in this case, there was very good collaboration, thank you very much.

01:22:14.070 --> 01:22:21.630
Karl Cogan (HPRA): Thanks very much have a great another great presentation some great great information there, and thanks to all our speakers, there are some wonderful wonderful presentation so.

01:22:21.930 --> 01:22:29.250
Karl Cogan (HPRA): i'll just hand straight over to matt and matt has going to give us the industry perspective and some industry kind of case studies so mass please over to you.

01:22:47.010 --> 01:22:47.790
Karl Cogan (HPRA): hey there.

01:22:48.060 --> 01:22:53.190
Derek Bonner (AV Support): hi matt this is Derek vivi support it looks like we're not able to hear you currently I see that you are unmuted, though.

01:22:57.240 --> 01:23:00.690
Emer Cooke: Well, I wouldn't be the same if we didn't have at least one technical problem.

01:23:18.180 --> 01:23:18.990
Emer Cooke: Paris.

01:23:21.090 --> 01:23:23.850
Theresa Mullin: Ross go to the second case study and come back to that.

01:23:25.980 --> 01:23:26.340
Boris Zimmermann: Good yeah.

01:23:27.720 --> 01:23:30.480
Boris Zimmermann: Can you please advance the slides to the second case study.

01:23:34.320 --> 01:23:35.010
Boris Zimmermann: One more.

01:23:38.340 --> 01:23:38.970
Boris Zimmermann: One more.

01:23:41.160 --> 01:23:57.990
Boris Zimmermann: Okay Hello everyone, my name is for Superman and i'm a senior director global quality control at genentech Roche it's my great pleasure to present a very exciting case study on behalf of the industry, which is the stability and shelf life modeling for Cobra 19 monoclonal antibody cocktail.

01:23:59.010 --> 01:24:10.200
Boris Zimmermann: So, clearly the cmc stability and chef live setting data are one of the most waste limiting factors and thinking of acceleration, or about the high emergency needs, such as.

01:24:11.010 --> 01:24:20.070
Boris Zimmermann: The complete 19 pandemic situation drug substance drug product chef life is based on available real time data which is still the norm for biologic products.

01:24:20.430 --> 01:24:31.290
Boris Zimmermann: However, statistical tools that are characterized stability behavior, for example, for ITT one monoclonal antibodies it exists and is established.

01:24:31.770 --> 01:24:50.820
Boris Zimmermann: And I have to say that while prior knowledge and respects approaches are commonly used to establish and set justify the manufacturing process and the control systems that are not so commonly used still instability clearly the covert 19 monoclonal antibody used in this case study.

01:24:52.320 --> 01:25:02.430
Boris Zimmermann: highlights the needs and the limited research and development and product specific stability data required a differentiated life setting approach.

01:25:03.120 --> 01:25:15.330
Boris Zimmermann: If you please go to the next slide this slide introduces the approach us modeling data of the two monoclonal antibodies in the cocktail derived from accelerated and stress stability studies.

01:25:15.780 --> 01:25:30.030
Boris Zimmermann: were used in combination with the Rangers theory in comparison of stability data with stress and available real time stability data from seminar monoclonal antibodies and similar formulations were considered.

01:25:30.480 --> 01:25:36.150
Boris Zimmermann: And the usage of a renewal smuggler was enabled by a tremendous knowledge gained.

01:25:36.720 --> 01:25:47.280
Boris Zimmermann: and significant process made towards understanding of temperature dependencies of monoclonal antibodies for predicting shelf life, including the limitation of the model.

01:25:47.850 --> 01:25:55.740
Boris Zimmermann: On top left you see the illustration of the high molecular weight formation arrhenius plot for the two monoclonal antibodies in the case study.

01:25:56.370 --> 01:26:09.330
Boris Zimmermann: In the renewals plot itself, you see the natural logarithm of the rate constant obtain for each temperature plotted against the inverse of the absolute temperature for the free temperatures us.

01:26:09.960 --> 01:26:19.260
Boris Zimmermann: And then the arrhenius equation obtained, which is for each attribute is then used to estimate the formation rate of high molecular weight species.

01:26:19.560 --> 01:26:30.420
Boris Zimmermann: At the five see which is the recommended started condition for the two monoclonal antibodies and this, you can see, on the two plots next to that removes plot.

01:26:31.920 --> 01:26:40.410
Boris Zimmermann: When you go to the next slide i'm already summarizing the case study truly the pandemic experience highlights the significant.

01:26:41.490 --> 01:26:50.760
Boris Zimmermann: potential to accelerate and overcome cmc stability challenges in the area of pre market, as illustrated in this case study.

01:26:51.810 --> 01:26:58.350
Boris Zimmermann: As an accelerated launch for setting initial shelf life, as well as postmarketing situations.

01:26:59.190 --> 01:27:09.330
Boris Zimmermann: Several health authorities, but not all accepted the shelf life modeling to set initial shelf life for the Corbett 19 anybody cocktail for emergency use.

01:27:09.810 --> 01:27:13.710
Boris Zimmermann: To commercial commercial value is currently ongoing, so we will see.

01:27:14.460 --> 01:27:26.130
Boris Zimmermann: But as heard from Sean presenting to us, the outcome of the regulatory survey and also from others today regulators are more open to flexible approaches for cmc stability.

01:27:26.460 --> 01:27:39.030
Boris Zimmermann: And this is definitely a key enabler for fast access and robust supply for critical products to patients, so thank you very much and I pass on to create him for the next case study.

01:27:41.970 --> 01:27:46.020
Matt Popkin: Before you pass on can I check my audio is now working it's matt here.

01:27:48.480 --> 01:27:49.470
Graham Cook: Yes, we can hear you.

01:27:50.340 --> 01:27:55.530
Matt Popkin: Wonderful Well let you carry on Graham and then and then i'll be the remedial one at the end apologies everyone again.

01:27:56.820 --> 01:28:02.850
Graham Cook: Okay, thank you hi everybody Graham cooke from Pfizer I working our quality operations on regulatory issues.

01:28:03.300 --> 01:28:11.790
Graham Cook: In this case study i'm going to share our experiences from the Community vaccine that was developed out of the Pfizer biotech collaboration, but i'm sure that.

01:28:12.090 --> 01:28:19.950
Graham Cook: similar stories can be told by colleagues in astros Annika Johnson and Johnson medan are about their vaccines, the Pfizer by on tech.

01:28:21.330 --> 01:28:33.540
Graham Cook: Collaboration was announced on the 17th of March last year and just 266 days later on the eighth of December, the first code vaccine approved for emergency use was administered to Margaret keenan in the UK.

01:28:34.200 --> 01:28:43.800
Graham Cook: Now this wasn't just the first code vaccine, but it was also the first example of a new platform and then Mr and a vaccine that was approved for emergency use.

01:28:44.760 --> 01:28:52.980
Graham Cook: Now this required and adjustment of the conventional paradigms Pfizer biotech and the regulatory authorities how to engage in the close and frequent dialogue.

01:28:53.280 --> 01:29:02.880
Graham Cook: That we've already heard about, to ensure that safe, effective and consistently reliable vaccine could be supplied and administered in over 100 countries around the world.

01:29:03.630 --> 01:29:12.810
Graham Cook: So what are these interactions look like when my colleagues we're having weekly and sometimes daily conversations with regulators in different agencies to agree and provide.

01:29:13.260 --> 01:29:23.910
Graham Cook: The necessary information for an emergency use authorization by our colleagues in those agencies, but I think we're already learning that this intensive use of human expert resources.

01:29:24.360 --> 01:29:29.640
Graham Cook: In this way, isn't really sustainable if I turn to the regulatory challenges and accomplishments.

01:29:30.000 --> 01:29:39.270
Graham Cook: it's important to highlight the challenge that we found in navigating the different pathways and requirements for emergency use that exist in the regulatory frameworks around the world.

01:29:39.780 --> 01:29:51.060
Graham Cook: These pathways can be flexible, but some markets are constrained by their legal framework now obviously one of the flexibilities that was used was rolling submission or dynamic regulatory assessment.

01:29:52.140 --> 01:29:56.970
Graham Cook: But because the product is evolving during the review, you can see why specifications for the product.

01:29:57.450 --> 01:30:13.560
Graham Cook: are established based on limited data might need to be considered as interim or provisional and, consequently, we made a series of commitments and obligations to provide additional data to confirm manufacturing consistency and quality after receiving authorization for emergency use.

01:30:14.700 --> 01:30:24.120
Graham Cook: Now, several paradigm shifts enabled these rapid reviews, in parallel with the development of the vaccine we developed a single dossier for all markets we didn't conduct.

01:30:24.510 --> 01:30:33.300
Graham Cook: Additional market specific studies, because we were focused on getting the vaccine to the market as fast as possible, because we recognize every day would save lives.

01:30:33.900 --> 01:30:47.910
Graham Cook: There was full transparency to enable appropriate benefit risk balance of the flexibility in regulatory expect expectations and processes, and we also saw some mutual respect reliance amongst regulatory authorities globally, we can move to the next slide please.

01:30:50.850 --> 01:31:01.770
Graham Cook: And, as well as the regulatory challenges, there were many technical challenges that needed to be overcome, I think, even the general public became aware of the ultra cold chain distribution challenges and our so called pizza boxes.

01:31:02.400 --> 01:31:06.570
Graham Cook: But of course there were many other problems that our scientists and engineers successfully tackled.

01:31:07.350 --> 01:31:17.910
Graham Cook: challenge that's particularly relevant to this workshop is the parallel development of manufacturing process and the analytical methods which are also being developed in parallel with the clinical Program.

01:31:18.540 --> 01:31:24.390
Graham Cook: So the control strategy clearly might need to be refined during development and then after authorization.

01:31:24.990 --> 01:31:30.270
Graham Cook: Based on the enhanced scientific understanding that we would gain from manufacturing experience.

01:31:31.260 --> 01:31:36.210
Graham Cook: As we've already heard, managing the addition of manufacturing sites to expand supplies a complex issue.

01:31:36.690 --> 01:31:45.210
Graham Cook: Connie mentioned the need to move products were kept create capacity in existing sites, while maintaining the supply of all the other medicines that we make.

01:31:45.720 --> 01:31:53.640
Graham Cook: And another issue that was addressed was, as we heard was adding new raw materials supplies for critical raw material, we went from having just a single supplier.

01:31:53.910 --> 01:32:02.400
Graham Cook: able to supply quantities just needed for clinical trials to five suppliers to ensure that we had a robust supply chain for the commercial process.

01:32:03.030 --> 01:32:09.060
Graham Cook: And why we're making all these changes, we need to demonstrate consistent quality across multiple sites and suppliers.

01:32:09.540 --> 01:32:15.390
Graham Cook: So this resulted in using different approaches to process validation that you can see described on this slide.

01:32:16.140 --> 01:32:24.600
Graham Cook: So if we think about the product lifecycle you can see how there has been an intense focus on managing the commitments made as a condition of emergency use approvals.

01:32:24.960 --> 01:32:34.710
Graham Cook: and also on the post approved post authorization changes that he needed to expand the supply to more than two and a half billion doses in 2021.

01:32:35.550 --> 01:32:39.630
Graham Cook: So what are our learnings and recommendations for considering consideration in this workshop.

01:32:40.140 --> 01:32:51.150
Graham Cook: you've heard how dialogue and collaboration between companies and regulators and a single global dossier was critical to our success and i'd like to finish by highlighting how important it is that we.

01:32:51.630 --> 01:33:00.480
Graham Cook: Work to enable the flexibility to meet regulatory requirements by using the kind of alternate approaches that have been discussed for example process validation.

01:33:01.080 --> 01:33:07.590
Graham Cook: That we harmonize global pathways and requirements for emergency use and conditional authorized marketing authorizations.

01:33:08.070 --> 01:33:20.490
Graham Cook: And that we enhance the practices for collaborative review and reliance so is to optimize the use of our expert human resources, both in companies and also in regulatory agencies so thanks very much back to you matt.

01:33:21.750 --> 01:33:25.020
Matt Popkin: Thank you, so if you can go back to the first industry case study.

01:33:31.680 --> 01:33:40.020
Matt Popkin: that's the one Thank you and just again apologies everybody for so far, being the only technical fault in the whole system, so if you go to the.

01:33:40.410 --> 01:33:44.970
Matt Popkin: Next slide please, and the only slide this slide is a summary of.

01:33:45.720 --> 01:33:54.780
Matt Popkin: The comparability and change an analytical challenges being faced in in this example, which is a monoclonal antibody for the treatment of covert 19.

01:33:55.170 --> 01:33:58.830
Matt Popkin: And then the table on the right, you can see, in in the three columns.

01:33:59.640 --> 01:34:11.160
Matt Popkin: Various elements to do with the manufacturing supply chain and control strategy that are changing between the late clinical and emergency youth authorization supply chain to.

01:34:11.700 --> 01:34:28.080
Matt Popkin: Supply Chain required for the marketing or application and early commercial supply and then the long term commercial supply a greater scale which needs to be brought on board rapidly post approval in order to in order to supply on the quantity required.

01:34:29.610 --> 01:34:35.610
Matt Popkin: So there's a lot of variables there that are changing and and therefore comparability, to support the change either a.

01:34:35.910 --> 01:34:44.160
Matt Popkin: Being able to justify that the product that is produced, following the change is equally safe efficacious and appropriate quality is an absolutely.

01:34:44.460 --> 01:34:51.240
Matt Popkin: essential part of any accelerated development program and it's vital to any pandemic therapy or vaccine.

01:34:51.990 --> 01:35:02.280
Matt Popkin: And and it's obvious that in order to enable this there needs to be a reliance on on science and risk based approaches to enable changes to things like the cell source.

01:35:02.760 --> 01:35:10.860
Matt Popkin: The new introduction new manufacturing sites changes to countries and the control strategy as well, so what does this look like in in in reality.

01:35:11.760 --> 01:35:14.790
Matt Popkin: Elements there that that we've drawn out are the context of.

01:35:15.330 --> 01:35:24.990
Matt Popkin: Changes being implemented through protocols and commitments you've heard a lot about that, but it's incredibly important, and this is still an area of innovation in biological products.

01:35:25.620 --> 01:35:33.870
Matt Popkin: elements such as batch analysis being done at the drug substance level where the changes have been introduced in the drug substance and not necessarily requiring.

01:35:34.230 --> 01:35:42.540
Matt Popkin: Further assessment and testing at the drug product level and elements you've heard about already today, such as the supporting stability if.

01:35:42.870 --> 01:35:53.280
Matt Popkin: On the basis of risk assessment it's actually required being conducted at the most appropriate place scientifically, which would be the drug substance rather than the drug product for a change for the drug substance process.

01:35:54.300 --> 01:36:00.780
Matt Popkin: you'll see as well there's other elements that we wanted to highlight here, and those are related to the analytical analytical testing.

01:36:01.260 --> 01:36:10.770
Matt Popkin: So this is a product that's produced at a third country outside of the EU in us and the testing on the drug substance is actually performed in testing science.

01:36:11.280 --> 01:36:21.930
Matt Popkin: And one of the concerns in this case is the wasteful importation testing being required potentially in both EU and US, whereas the same testing could occur in just one of those areas.

01:36:23.220 --> 01:36:35.190
Matt Popkin: Another key point around analytical testing is to significant time and and technical and regulatory resource required to conduct tech transfer and validate the testing multiple sites.

01:36:35.640 --> 01:36:50.640
Matt Popkin: And in this case, it was amplified because additional testing was also a requirement of the emergency use authorization, so this is all the same technical resource inside industry and regulatory authorities being asked to do elements which perhaps weren't required.

01:36:51.690 --> 01:37:00.270
Matt Popkin: And then the last part there that we've called out is this idea, relative to the control strategy where we're implementing a cell based buyer s&c for potency.

01:37:00.600 --> 01:37:15.810
Matt Popkin: At the point, as is normally the case of the commercial product, but in fact we could continue potentially using the Elisa potency testing through into the early commercial lifecycle and introduce that testing, as opposed to people commitment.

01:37:16.920 --> 01:37:24.570
Matt Popkin: So That was all I wanted to say, in the context of the example I just finished by by saying or reiterating what my colleagues have said, around.

01:37:25.080 --> 01:37:33.120
Matt Popkin: This science and risk based approach being essential, and if you can imagine the amount of discussions around all these variables that need to occur.

01:37:33.510 --> 01:37:51.630
Matt Popkin: between industry and just one regulatory authority and then you multiply them across all of the authorities where dialogue is required, it starts to be a significant burden that in the future, we hope, discussions like today's can address and streamline significant.

01:37:53.820 --> 01:37:56.880
Matt Popkin: Call i'm lost where we go next so i'll hand it back to.

01:37:56.880 --> 01:38:14.250
Karl Cogan (HPRA): yeah so no thanks very much Madsen some really interesting presentations there, so I think we're kind of coming up to a break now, and so I know we're a little bit behind time, and so we have one scheduled so emerging do you want to shorten the break or will we go for 10 minutes.

01:38:14.670 --> 01:38:27.780
Emer Cooke: And I think we might as well take advantage of the fact that we're all in remote settings and we don't have to go in and out of the room and we just take a five minute break if that's okay.

01:38:29.280 --> 01:38:36.000
Emer Cooke: So that would be fun and on the 45 a quarter to that we would come back.

01:38:36.330 --> 01:38:54.660
Emer Cooke: And at that point we'll be coming back to the first of three panel discussions and the first panel is moderated by lori Lee from FDA so laurie if you would be ready and everybody else back in the room at 45 quarter to the hour, thank you very much.

01:39:52.860 --> 01:39:56.940
Emer Cooke: Can I please check if we're ready to proceed with pamela one.

01:39:58.830 --> 01:40:01.560
Sau Lee: Yes, we're ready excellent.

01:40:02.040 --> 01:40:03.240
Sau Lee: Thank you very much.

01:40:03.750 --> 01:40:04.830
Emer Cooke: Over to you all right.

01:40:05.940 --> 01:40:13.290
Sau Lee: Thank you, Mr yeah let's get started on Larry lead let's go to the first question directly.

01:40:15.030 --> 01:40:37.590
Sau Lee: To the to to our panelists What would you describe as your number one lesson learnt from covering 19 experience today and which facility or activities in cmc de la requirement that you think could be retained in the post pandemic period, Graham I start with you first.

01:40:39.120 --> 01:40:46.050
Graham Cook: Thanks very much Larry yeah I think this has been a really interesting discussion i'm perhaps gonna sound a little bit like a broken record, because I think that.

01:40:47.130 --> 01:40:53.040
Graham Cook: As you heard from our case study frequent effective communications between companies and agencies are critical.

01:40:55.710 --> 01:41:03.810
Graham Cook: When they're probably not sustainable in the way they've been happened happening and so thinking a little bit about how do we fix that.

01:41:04.170 --> 01:41:14.670
Graham Cook: I think there are perhaps three things to consider third further one reliance mechanisms to enable regulators through lap to collaborate and assess the scientific data just one time.

01:41:15.720 --> 01:41:19.500
Graham Cook: Supported by a single global dossier, which we also mentioned in our case study.

01:41:20.190 --> 01:41:28.830
Graham Cook: And then perhaps that could also be facilitated by establishing agreed common standards for regulatory requirements and flexibility for submissions in pandemics.

01:41:29.220 --> 01:41:42.210
Graham Cook: That would help optimize resources, and I think if you think about all of those aspects could also be considered for use kind of post pandemic so i'll stop there, and conscious of the time let others perhaps continue back to you.

01:41:43.740 --> 01:41:50.280
Sau Lee: know, thank you, Graham hancock from working toward perspective can you actually give some comments to this question.

01:41:50.700 --> 01:41:52.560
Karl Cogan (HPRA): yeah sure sure Larry and.

01:41:53.040 --> 01:41:58.410
Karl Cogan (HPRA): Just one very, very kind of quick comment before I address that I think I think is really important to acknowledge kind of.

01:41:58.710 --> 01:42:04.140
Karl Cogan (HPRA): How far we've come in the last kind of 18 months we've gone from an unknown infectious disease.

01:42:04.530 --> 01:42:10.620
Karl Cogan (HPRA): To the development of safe and effective vaccines within within a year it's an incredible achievement and it's.

01:42:11.010 --> 01:42:18.000
Karl Cogan (HPRA): Only due to the phenomenal effort by so many people so from basic biomedical research as the pharmaceutical industry.

01:42:18.240 --> 01:42:30.600
Karl Cogan (HPRA): Regulators and also clinical trial participants, so I just think it's important to recognize that and put this conversation into context, when we talk about things that we can do better we've done a good job, but it's no harm kind of looking back as well.

01:42:31.260 --> 01:42:35.370
Karl Cogan (HPRA): And if you were putting me on the spot in terms of a REG shoe position in.

01:42:36.570 --> 01:42:50.460
Karl Cogan (HPRA): i'm saying it like a broken record grams emphasize it everybody's emphasizing the importance of really transparent, open communication is vital to really capitalize on the flexibilities that have been put in place.

01:42:50.850 --> 01:42:58.230
Karl Cogan (HPRA): prioritize the key data that's really needed to maximize those flexibilities So if I had to pick one lesson learned.

01:42:58.530 --> 01:43:03.240
Karl Cogan (HPRA): it's definitely focusing on improvement and have our back key communication.

01:43:03.570 --> 01:43:13.740
Karl Cogan (HPRA): In terms of agility is to bring forward there's there's multiple I think we could probably better use or kind of utilize more widely, the post approval change management plans.

01:43:14.220 --> 01:43:22.590
Karl Cogan (HPRA): And and Boris present presented some nice data there in terms of modeling and the application modeling and I think that's really it's a really kind of good example.

01:43:22.980 --> 01:43:34.320
Karl Cogan (HPRA): That we can use different data not limited data just different data to help bridge the gap between the known and the unknown, while we wait for us more that confirmatory data and then.

01:43:34.770 --> 01:43:43.320
Karl Cogan (HPRA): I think remote inspections are obviously a win as well, so I think those three could definitely be progressed beyond kind of the pandemic so i'll stop there, and.

01:43:44.820 --> 01:43:48.900
Sau Lee: yeah Thank you call while feel for a visa oh yes.

01:43:49.800 --> 01:43:51.090
Raphael Pereira: I agree totally.

01:43:51.150 --> 01:43:52.830
Raphael Pereira: With car and I think that.

01:43:53.880 --> 01:44:02.520
Raphael Pereira: transfer in advance that communication is is the key, but it's also a big challenge because it's it's hard to.

01:44:03.720 --> 01:44:12.570
Raphael Pereira: keep this communication with so many sponsors, with so many products so it's always important that companies group.

01:44:13.590 --> 01:44:30.540
Raphael Pereira: similar cases, the post approval change management plan it's a very interesting to for us to use at this case and but communication and early communication I think it's it's, the most important lesson that we learned he.

01:44:31.650 --> 01:44:32.010
Raphael Pereira: Thank you.

01:44:32.490 --> 01:44:42.810
Sau Lee: yeah Thank you Sophia, let me just open up the floor to all of our panelists to see if they have any additional quick comments to this question anyone.

01:44:47.730 --> 01:44:54.660
Sau Lee: Okay, if we don't have any additional common let's go to the second question, the second question is.

01:44:55.170 --> 01:45:14.070
Sau Lee: Regulators a industry align on the priority key regulatory mechanisms enforceability festivals cmc approaches that are most critical If not, what are the gaps are met from JFK why don't you start with.

01:45:15.180 --> 01:45:16.170
Sau Lee: This one first.

01:45:17.070 --> 01:45:19.890
Matt Popkin: Thank you Larry and just checking my audio again, just in case.

01:45:20.700 --> 01:45:21.210
Stelios Tsinontides, FDA: Yes, yep.

01:45:21.270 --> 01:45:24.240
Sau Lee: you're good that's great Okay, so I think.

01:45:24.600 --> 01:45:30.540
Matt Popkin: Hopefully, everyone has seen already from what's been shared today, in the case studies in the presentation, so there is a strong alignment.

01:45:31.290 --> 01:45:48.750
Matt Popkin: And what I would say is actually that lineman is something that predates the pandemic, so you only have to go back to 2018 to recall that the FDA and the AMA organized a really significant meeting in London on.

01:45:50.730 --> 01:45:59.550
Matt Popkin: cmc quality approaches to products in the prime or breakthrough program so for medical need and hugely productive.

01:46:00.480 --> 01:46:06.390
Matt Popkin: exercise that was with lots of key learnings coming out and the AMA this year, in fact, published a draft of their.

01:46:06.900 --> 01:46:10.140
Matt Popkin: toolbox from medical need and I i'll go so far as to say.

01:46:10.620 --> 01:46:20.250
Matt Popkin: it's my personal view that if that hadn't been done that exercise hadn't been there, we wouldn't have had the foundation for so much of what we've heard about today has been actually implemented.

01:46:20.700 --> 01:46:27.030
Matt Popkin: For for code 19 therapies and I think that tells you the value of collaboration and the level of alignment.

01:46:27.660 --> 01:46:36.900
Matt Popkin: Where other areas still to focus on I guess the reliance piece you've heard that from industry, time and again, and the complexity of having multiple early engagements.

01:46:37.530 --> 01:46:43.290
Matt Popkin: I think there is a tension in terms of everyone's time and resource which impacts supply and therefore impacts patients.

01:46:43.710 --> 01:46:49.080
Matt Popkin: of having to have lots of discussions with lots of regulators and the more and more frequent they are.

01:46:49.710 --> 01:47:00.870
Matt Popkin: The greater that tension is on terms in terms of the the amount of work required and the potential impact of it, but I think those are areas to solve the problems and and i'll finish by saying.

01:47:01.920 --> 01:47:11.040
Matt Popkin: The one other area that i'm really impressed on in terms of alignment is some of the points that have been used for covert are really going to be.

01:47:11.370 --> 01:47:20.070
Matt Popkin: I think built into future global approaches and you can only you need to look at what's what's on the cards now for updates to Ice Age guidance on specifications and stability.

01:47:20.460 --> 01:47:33.690
Matt Popkin: To understand that a lot of what we've heard about today and what has had to be used as a scientific tools and it's actually going to be built into updates to the ic H guide, and so I think it's looking very promising for the future.

01:47:35.970 --> 01:47:44.820
Sau Lee: Now, thank you matt how about Maria from health Canada can you provide your perspective from a regulatory side.

01:47:45.660 --> 01:47:46.620
Sau Lee: I think I.

01:47:46.650 --> 01:47:48.420
Maria Baca-Estrada: definitely agree with has.

01:47:48.570 --> 01:47:57.450
Maria Baca-Estrada: What has been discussed so far, but I think i'd like to also reflect on something we we don't talk to, too often, and it is the.

01:47:57.780 --> 01:48:05.340
Maria Baca-Estrada: alignment between the different companies and what I wanted to say, with this is, we have seen from the experience in the last year.

01:48:06.180 --> 01:48:17.400
Maria Baca-Estrada: How different approaches have been taken in terms of product development scale up or scale out quickly before many of the items are well intensify and.

01:48:18.060 --> 01:48:22.290
Maria Baca-Estrada: That creates challenges, for example, so we have seen different approaches in that.

01:48:22.770 --> 01:48:33.030
Maria Baca-Estrada: And another another thing that comes to mind, just as an example of how different principles have been adopted by industry in terms of, for example, establishment of.

01:48:33.390 --> 01:48:38.310
Maria Baca-Estrada: Release and shelf life specification, which is something very important for vaccines.

01:48:38.820 --> 01:48:53.040
Maria Baca-Estrada: there's different principles been adopted, and I mean I think those are aspects that just reflect the fact that there's also a need for having a bit more of harmonization in the basic principles that.

01:48:53.910 --> 01:49:02.400
Maria Baca-Estrada: need to be taken for product development is just a comment in regards to some of the gaps Thank you back to you learn.

01:49:03.840 --> 01:49:06.210
Sau Lee: yeah Thank you Maria and Boris.

01:49:07.380 --> 01:49:09.570
Sau Lee: From Jeanette Roche.

01:49:10.650 --> 01:49:20.910
Boris Zimmermann: yeah Thank you Larry I mean a lot was already set from it and others you the question is about other any gaps right, and I mean.

01:49:21.540 --> 01:49:30.450
Boris Zimmermann: There is great collaboration, for many, many years of industry and regulators and there is a great foundation so from my perspective, there are no true gaps.

01:49:30.870 --> 01:49:39.150
Boris Zimmermann: And it's more a bit about the how right, the amount of data, information, knowledge, provided the challenges.

01:49:39.510 --> 01:49:48.780
Boris Zimmermann: Of the scientific and risk based approaches which are highly case by case or product class specific like the ITT ones, for example.

01:49:49.710 --> 01:50:02.160
Boris Zimmermann: All the areas right, where I could may be beneficial to further discuss about those details and how this data packages and how the information should be provided to the health authorities.

01:50:02.940 --> 01:50:24.150
Boris Zimmermann: are mentioned as well today it's the comparability exercises it's the Stability example it's the justification of the specification and process validation so a good foundation, but to really be fast, there needs to be a better understanding what is really needed from a regulatory perspective.

01:50:25.860 --> 01:50:27.150
Boris Zimmermann: Thank you yeah thank.

01:50:27.300 --> 01:50:38.850
Sau Lee: You, thank you for your perspective that's great and then, what do I think you also may have some comments regarding this question, please share your comment, thank you.

01:50:38.880 --> 01:50:59.550
Raphael Pereira: Just a quick comment it's I agree with what everybody said just a quick comment, sometimes it's difficult to put industry in the same box as a whoa association, because we have different types of industries, we have national industries international industries and.

01:51:00.750 --> 01:51:10.800
Raphael Pereira: We have a general thinking that reliance tools are important but it's sometimes difficult to consider what are the top priority.

01:51:12.270 --> 01:51:28.440
Raphael Pereira: Issues what should be addressed first I think that's maybe it's not really a gap, but it's something that we should take care of the priorities are not always very clear in a, we are not always in the same page.

01:51:30.000 --> 01:51:30.690
Raphael Pereira: that's all thank you.

01:51:31.860 --> 01:51:33.660
Matt Popkin: yeah Thank you all for your arm.

01:51:33.690 --> 01:51:42.810
Sau Lee: Let me just open up the for a little bit to see if any other panels members have any additional comments to this question anyone.

01:51:45.030 --> 01:51:45.540
Matt Popkin: i'm a.

01:51:45.990 --> 01:51:46.350
Karl Cogan (HPRA): i'm sorry.

01:51:46.380 --> 01:51:46.740
Matt Popkin: i'm sorry.

01:51:47.010 --> 01:51:48.060
Karl Cogan (HPRA): Work away now we're going.

01:51:48.900 --> 01:51:49.050

01:51:50.280 --> 01:51:53.610
Matt Popkin: go very quick it's just to say, I think, to build on raphael's point.

01:51:54.660 --> 01:52:03.930
Matt Popkin: If we have to have individual discussions between every company and every agency to understand what's appropriate we're going to get more diversity and we're going to it's going to take more time.

01:52:04.410 --> 01:52:13.560
Matt Popkin: So it's really important that coming out of this exercise, what is appropriate, on a case by case basis, but but appropriate and different from the normal.

01:52:14.070 --> 01:52:24.750
Matt Popkin: I feel that needs to be documented and it needs to be something that companies can come to as a first intent and i'll say a toolbox for for acceleration because.

01:52:25.890 --> 01:52:38.790
Matt Popkin: Because otherwise it's actually counterproductive to not have that that the certainty required everything is case specific but there needs to be a framework and everyone is agreed to address these situations is my personal view.

01:52:41.250 --> 01:52:46.410
Sau Lee: Thank you, your points are well taken I call you have additional comments.

01:52:49.620 --> 01:52:49.980
Carl current.

01:52:52.920 --> 01:52:55.980
Stelios Tsinontides, FDA: laurie maybe I can make a comment okay.

01:52:56.370 --> 01:52:58.980
Stelios Tsinontides, FDA: I think that Maria Brody DARPA.

01:52:59.040 --> 01:53:07.140
Stelios Tsinontides, FDA: The need for a being able to farm Ionized in some way or another specification see, we have a way.

01:53:07.410 --> 01:53:19.140
Stelios Tsinontides, FDA: We are all of the regulatory agencies would come together in some way or another, and and agree on on a common set of specifications that will definitely enable.

01:53:19.470 --> 01:53:33.750
Stelios Tsinontides, FDA: The industry and the sponsors to really apply and and really accelerate the approval process through the various regulatory agencies, I think that's a challenge for us and that's an area.

01:53:34.770 --> 01:53:35.550
Stelios Tsinontides, FDA: We can improve.

01:53:39.330 --> 01:53:39.510
Sau Lee: On.

01:53:40.860 --> 01:53:44.940
Sau Lee: Any additional comments sorry yeah sorry about that.

01:53:45.390 --> 01:53:55.470
Karl Cogan (HPRA): Yes, we do, yes, whether it's not great today and yeah no it's just very quick kind of 30 seconds like I think we're all kind of very much aligned in terms of where we need to go and then.

01:53:55.740 --> 01:54:03.090
Karl Cogan (HPRA): Sometimes it takes a challenge to the system, it takes a stress in the in the form of a pandemic, to really kind of test our systems and see.

01:54:03.420 --> 01:54:12.900
Karl Cogan (HPRA): Where we can improve what's working well, so I think we're all figuring this out at the moment, but like kind of maybe the the pandemic will really help us to kind of clarify some of our thinking and.

01:54:13.410 --> 01:54:20.520
Karl Cogan (HPRA): we've had like almost this natural experiment, or we can kind of test some of these kind of regulatory kind of approaches which is really nice and.

01:54:20.790 --> 01:54:33.780
Karl Cogan (HPRA): kind of there'll be a really kind of detail kind of respect or reflective kind of piece looking now we're kind of really seeing what what was effective here, but sometimes it just takes a challenge for us to to sort out what's what's working and what's well.

01:54:35.880 --> 01:54:40.350
Sau Lee: Thank you call you know I think you saw time to go to our last question.

01:54:40.890 --> 01:55:01.200
Sau Lee: The last question is what would you describe as your number one recommendation to lessen though regulatory authorities to enable rapid increase in manufacturing capacity, let me turn to stereo why don't you go ahead, go ahead and start answering this question first from FDA.

01:55:02.130 --> 01:55:05.040
Stelios Tsinontides, FDA: Thank you laurie i'll give you a shot.

01:55:05.400 --> 01:55:20.430
Stelios Tsinontides, FDA: As I look at the way we handle multiple requests over the past year, I believe that the most important element that facility that those requests and our ability to approve.

01:55:20.940 --> 01:55:32.040
Stelios Tsinontides, FDA: obligations and side is is knowledge, apart from the, of course, the constant and transparent communication, the ability to share knowledge.

01:55:32.370 --> 01:55:44.340
Stelios Tsinontides, FDA: and get to know about the particular application and the side is very, very critical going back to do we need to go and do a pre approval or pre license inspection.

01:55:44.670 --> 01:55:59.580
Stelios Tsinontides, FDA: So an ability between regulatory agencies to share that knowledge and enables enables us to make decisions based on risk and science, and I believe.

01:56:01.230 --> 01:56:04.590
Stelios Tsinontides, FDA: That a commendation are going to have these two industry.

01:56:04.620 --> 01:56:18.330
Stelios Tsinontides, FDA: is to be very cognizant as they come to the agencies to utilize signs that they have it demonstrated record of quality and I will pinch here.

01:56:18.570 --> 01:56:23.400
Stelios Tsinontides, FDA: Our concept in our picture the FDA for quality maturity management.

01:56:23.700 --> 01:56:34.560
Stelios Tsinontides, FDA: That is that the side have demonstrated that they have put in place a variety of tools and processes that are shoes, the high quality products.

01:56:34.770 --> 01:56:44.580
Stelios Tsinontides, FDA: And do not rely upon the submission of that aggregation to prove that to us but Eve, they have demonstrated record and if we have the knowledge.

01:56:44.880 --> 01:56:55.020
Stelios Tsinontides, FDA: It will facilitate the utilization of alternate tools and also accelerated our regulatory review process, because at the end of the line at the bottom.

01:56:55.440 --> 01:57:08.880
Stelios Tsinontides, FDA: Is the patient safety, we cannot afford to send any product to patients that are is not high quality and doesn't meet the quality standards, to make sure that it is affected and safe, I will stop there.

01:57:10.680 --> 01:57:19.320
Sau Lee: Thank you, so let me go to college from Pfizer to to share his.

01:57:20.430 --> 01:57:24.150
Sau Lee: Industry perspective Connie Thank you Larry.

01:57:24.990 --> 01:57:36.480
Connie Langer: I think during the opening presentation from industry, we highlighted a few different recommendation so it's it's difficult to pick just one, and also to understand that really the collective.

01:57:36.480 --> 01:57:38.460
Connie Langer: Implementation of all of them.

01:57:39.690 --> 01:57:42.600
Connie Langer: would help with the regulatory agility but.

01:57:43.650 --> 01:57:58.230
Connie Langer: If I had to choose just one, I guess, I would say it is the one single dossier so alignment of requirements for things like post approval changes among the different agencies would really go a long way to.

01:57:58.680 --> 01:58:10.890
Connie Langer: Decreasing the timelines for the initial submission and and as well as the review for those packages and then that therefore enhance the manufacturing capacity.

01:58:13.410 --> 01:58:21.120
Sau Lee: to conduct candy and then let's go to call opening from from your perspective, what do you think is our number one priority.

01:58:22.560 --> 01:58:27.210
Karl Cogan (HPRA): I think stelios hit the nail on the head when he said that our ultimate goal is this.

01:58:27.330 --> 01:58:33.480
Karl Cogan (HPRA): Is the patient safety and regulatory regulatory flexibilities doesn't mean a lower standard.

01:58:34.080 --> 01:58:41.970
Karl Cogan (HPRA): Man I think that's I think it's really important so regulatory flexibilities in themselves are enablers because it really does need to be.

01:58:42.420 --> 01:58:56.430
Karl Cogan (HPRA): Combined with that communication collaboration engagement was really kind of backed up by data and it's it's really kind of a data driven kind of approach to this, and I can kind of emphasize this, and more an off.

01:58:57.030 --> 01:59:09.330
Karl Cogan (HPRA): Like so while we can accept reduce data sets we still need to see additional data that mitigates that risk, so we still need to be see manufacturing experience platform approaches prior knowledge.

01:59:09.840 --> 01:59:23.760
Karl Cogan (HPRA): and change management plans compatibility to So these are all things so again regulatory flexibility doesn't mean lower standard and it's also something that shouldn't be seen necessarily from the regulator only perspective but almost.

01:59:24.090 --> 01:59:33.330
Karl Cogan (HPRA): A joint enterprise between regulators and industry to get it to get this Royce and so it's it's important that.

01:59:33.780 --> 01:59:37.230
Karl Cogan (HPRA): The more process knowledge that we have or that's demonstrated.

01:59:37.470 --> 01:59:45.060
Karl Cogan (HPRA): The higher flexibilities that can be introduced so flexibilities in themselves aren't going to be a game changer it's when you combine that with the data.

01:59:45.240 --> 01:59:52.980
Karl Cogan (HPRA): combine that with the engagement to create that environment stand that's then that's where we really kind of maximize the benefit of those tools.

01:59:55.110 --> 02:00:10.890
Sau Lee: Like your call just so so in order to balance to achieve about is the true, though regulators industry i'm going to call our grand ham on Maybe you can also pick another number one of accommodation from the industry perspective.

02:00:11.730 --> 02:00:12.270
Graham Cook: or you're.

02:00:12.510 --> 02:00:14.580
Graham Cook: Just magic that rethinks with that.

02:00:14.580 --> 02:00:18.840
Graham Cook: Because I was going to call out the fact that i've been working as some of you probably know.

02:00:19.110 --> 02:00:22.110
Graham Cook: Within the ice HQ 12 expert working group, since.

02:00:22.140 --> 02:00:28.080
Graham Cook: 2014 and preparing for that for several years beforehand so i've given maybe 10 plus years of my life.

02:00:29.190 --> 02:00:40.440
Graham Cook: Focusing on product lifecycle management, which is what we're talking about here, so what I would suggest is let's build on the things that we're already doing embrace Q 12 concepts and principles.

02:00:41.010 --> 02:00:56.160
Graham Cook: and try and collectively work over the coming years to embrace those concepts and really embed them into the way we work to to facilitate what we're talking about here in terms of expanding manufacturing and supply capacity capabilities in these kind of programs thanks Larry.

02:00:57.840 --> 02:01:08.820
Sau Lee: Thank you, Graham I think i'm just waiting for someone to mention the future and you Dave Thank you so much, and i'm going to open up the for to see if any other regulate.

02:01:09.690 --> 02:01:23.850
Sau Lee: regulate the panelists from both our regulators, I, as well as industry size to have any other additional comments to this question, as well as to this panel discussion.

02:01:28.320 --> 02:01:33.990
Will Lewallen FDA: hi Larry there appears to be a couple questions in the Q amp a section I don't know if some of those would be addressed that panel.

02:01:40.230 --> 02:01:50.490
Sau Lee: yeah I think we can just go ahead and let let let me see Lisa just one question Okay, I think we still have a little bit time.

02:01:51.210 --> 02:02:08.610
Sau Lee: So from the panelists perspective, what is the elephant in the room, that we should adjust to enable access to critical medicines and progress concepts lesson learned for broader use so anyone want to take this question.

02:02:13.350 --> 02:02:29.130
Matt Popkin: I I give you a go I got a couple of elephants in the room apologies it's not a very it's not a very comfortable I guess some some of the things that some of the things that we need to think about is the global picture the true global picture.

02:02:30.600 --> 02:02:39.090
Matt Popkin: there's regulatory authorities there's billions of people therefore represented missing from today's discussion and we've got to take a global view.

02:02:40.740 --> 02:02:43.290
Matt Popkin: A really truly global view which means.

02:02:44.430 --> 02:02:56.640
Matt Popkin: All of the major well well everyone means the whole planet, I mean everyone knows what global means right, so I think that's a significant step change in terms of what we're looking to achieve if we really think about that.

02:02:58.440 --> 02:03:10.590
Matt Popkin: And I guess the second one is I mean i've said it a couple of times around the the difficulty of having multiple discussions and that whole reliance piece it I everyone's talked about reliance.

02:03:11.760 --> 02:03:25.380
Matt Popkin: what's going to happen what's because because, ultimately, where where is that going in terms of reliance what what's the honest moonshot goal that the regulators have in terms of reliance and and how do we deal with.

02:03:27.510 --> 02:03:42.690
Matt Popkin: How do we deal with the government's and legal situations that hours to address that and are we are we setting ourselves up with that goal, but those are kind of two bits that that that yeah and love to love to hear how this us on those.

02:03:43.950 --> 02:03:48.900
Sau Lee: yeah for the interest of time, I will stop here, but thank you.

02:03:49.410 --> 02:04:06.540
Sau Lee: Thank you very much for all the panelists I think you're right now, you said, the basis for further discussion, I think I will turn bad to Emma to introduce the next panel discussion, which is about lifecycle management moderated by Marcus from Roche, thank you.

02:04:07.350 --> 02:04:08.820
Emer Cooke: Thank you very much, sorry i'm.

02:04:08.820 --> 02:04:11.460
Emer Cooke: thanks for a fascinating panel discussion.

02:04:11.640 --> 02:04:24.510
Emer Cooke: And for keeping to the time, and so I think we're almost caught up, and I would hand over then to Marcus to talk to moderate this panel on.

02:04:25.080 --> 02:04:37.050
Emer Cooke: lifecycle management management tools challenges, a key learnings, but of course we come back to some of the key messages coming out of the previous panel discussion as well over two markets, please.

02:04:37.680 --> 02:04:48.780
Markus Goese: Thank you very much, in my hope you can all hear and see me well, so my name is Marco squeezy i'm working for Russian Switzerland and represent FP and the global industry in this workshop today so it's really a great pleasure to.

02:04:49.290 --> 02:04:52.860
Markus Goese: be able to moderate a panel through on lifecycle management today.

02:04:53.970 --> 02:05:05.670
Markus Goese: And as, as has been mentioned before, so in this session we will try to further explore the concepts challenges and approaches highlighted in the regulatory flexibility and industry presentations that have been previously shown in the workshop.

02:05:06.420 --> 02:05:12.900
Markus Goese: With a specific focus on lifecycle management of both call with therapeutics as well as vaccines and hopefully.

02:05:13.410 --> 02:05:19.440
Markus Goese: This will also help us to minimize the regulatory complexity and resource challenges of possible with change management.

02:05:19.890 --> 02:05:28.770
Markus Goese: Actually, for both for regulators and industry during the remainder of the pandemic and and probably also for future health emergencies so.

02:05:29.310 --> 02:05:42.840
Markus Goese: it's my pleasure to welcome to the panel and some panelists you have obviously seen before, for so my pleasure to welcome to falling panelists it's again if Tokyo quirky entity from EMI.

02:05:43.980 --> 02:05:49.800
Markus Goese: On the panel head of quality and safety, I will come again Maria buckeye stronger from health Canada.

02:05:51.030 --> 02:06:02.130
Markus Goese: division of bacteria in combination of vaccines, I will come again refer Pereira from on visa is in from the office of quality evaluation for small molecules and we have a new panelists.

02:06:02.670 --> 02:06:11.010
Markus Goese: I hope he will be able to join us, this is Mohammed and military from SF da Saudi Arabia he's the head of post marketing variations.

02:06:12.000 --> 02:06:24.180
Markus Goese: I welcome, of course, as well from industry side diane Wilkinson she's senior director at astros Annika representing vaccines Europe and I do welcome to carry gastineau from.

02:06:24.990 --> 02:06:29.460
Markus Goese: Sanofi global head of quality advocacy also representing vaccines Europe.

02:06:30.300 --> 02:06:41.100
Markus Goese: Quick announcement, I was, I would like to inform you that we have unfortunately received apologies from two colleagues on short notice Patricia prayer from the Argentinian authority and not, as well as Suresh.

02:06:41.520 --> 02:06:48.360
Markus Goese: Today, from DC vm and they are both unfortunately ill today and cannot join the panel, so we wish them fast recovery.

02:06:50.280 --> 02:07:01.230
Markus Goese: Now, in the interest of time, I would like to jump right into the questions we have prepared several questions for this panel, and I would like to start with industry and Terry.

02:07:02.190 --> 02:07:09.990
Markus Goese: Terry so as we have also said already seen today the manufacturer of of covered 19 therapeutics and vaccines can involve many.

02:07:10.500 --> 02:07:24.360
Markus Goese: Dozens of manufacturing and testing size per product so from an industry perspective, what is for you, the greatest challenges challenge with introducing and managing post approval changes across such a large number of sites.

02:07:25.350 --> 02:07:33.480
Thierry Gastineau: As I think Marcus hi everyone, first of all I would like to say that i'm Speaking on behalf actually of vaccines Europe, and we have actually a task force.

02:07:34.440 --> 02:07:41.010
Thierry Gastineau: of multiple vaccine manufacturers, so this is not only my Sanofi pastor point of view that i'm going to read present so.

02:07:41.850 --> 02:07:48.630
Thierry Gastineau: I think that i'm going to to rise to pick what matt was saying before about the complexity and the global topic.

02:07:49.260 --> 02:07:55.050
Thierry Gastineau: So what I would like to to say it, for me, there are two key words amplification and complexity.

02:07:55.800 --> 02:08:06.240
Thierry Gastineau: The first thing is about the complexity and I think it was also said in the previous presentation and recognize, I think, by Sean very at the very beginning, also, that there is a level of complexity.

02:08:06.660 --> 02:08:16.170
Thierry Gastineau: At the moment, on a routine basis on the management of possible changes on lifecycle management, now the topic or the issue that that we have, and it has been settled with the.

02:08:16.830 --> 02:08:28.920
Thierry Gastineau: shoe times and very well illustrated that there is actually an amplification due to the Corbett situation because of multiple things, the first thing is that we need to manage more possible changes.

02:08:29.310 --> 02:08:33.270
Thierry Gastineau: Just for the simple reason that there has been actually I mean a.

02:08:33.870 --> 02:08:44.310
Thierry Gastineau: condensed development of of vaccines vaccines and therapeutics so, meaning that a number of things have not been able to be submitted at the initial time of submission.

02:08:44.610 --> 02:08:56.130
Thierry Gastineau: And that needs to be managed post approval so that's one thing, the second thing is that that is a lot of things, indeed, and this is, this has been very well I just tweeted by the presentation from Africa and shown.

02:08:56.820 --> 02:09:09.870
Thierry Gastineau: With with with the metrics from the EU, with the first possible changes from the first faxing manufacturers, with this, I mean compressed timing, during which there has been quite or already lot of possible changes.

02:09:10.650 --> 02:09:23.160
Thierry Gastineau: The The third thing is that, in terms of amplification, as you just said molecules is that this is actually an unprecedented situation whereby actually we have a huge footprint interest would footprint.

02:09:23.760 --> 02:09:36.420
Thierry Gastineau: This is the first time in my in my own life that testing that and certain number of you so that means that this is adding an additional layer of complexity and why is because when you need to manage actually supposed to pull change.

02:09:37.230 --> 02:09:42.720
Thierry Gastineau: To work today with the current situation from an industry perspective, this single possible change.

02:09:43.050 --> 02:09:53.220
Thierry Gastineau: You want to manage it consistently across hopefully consistently across multiple manufacturing sites, so there is an amplification of this complexity.

02:09:53.580 --> 02:10:02.040
Thierry Gastineau: Due to this situations and actually this this this footprint now what I would like also to sign in terms of complexity and the challenge and that's why.

02:10:02.400 --> 02:10:11.700
Thierry Gastineau: I was mentioning what matt was saying before is the global challenge because let's imagine actually this single one poster board change.

02:10:11.940 --> 02:10:22.830
Thierry Gastineau: multiplied by the number of of manufacturing sites and, of course, you need to demonstrate compatibility and so on, but you need to manage that, on a country by country basis, I think it has been illustrated.

02:10:23.310 --> 02:10:37.350
Thierry Gastineau: A few times, so there is an absolute need, and I think, indeed, a challenge to find ways to have flexible approaches, it has been said, multiple times and actually if we take a let's say a conventional approach by which.

02:10:37.770 --> 02:10:47.430
Thierry Gastineau: For example, for one single pack you're going to 213 P P two batches, for example on the drug substance and also potential in the drug product.

02:10:47.850 --> 02:10:51.660
Thierry Gastineau: I mean, this is not something that you can manage at this point in time.

02:10:51.930 --> 02:11:05.010
Thierry Gastineau: With the dozens actually of manufacturing sites, so there is a need to to have some risk based approaches, this has been settled with you a few times so that this is accepted Now the challenge once again and i'm sure that we're going to discuss that.

02:11:05.610 --> 02:11:19.950
Thierry Gastineau: During the panel discussion is how to manage that, actually, I mean across all the regulatory and still heterogeneous landscape worldwide landscape, so I think that's that's the big big challenge according to industry.

02:11:20.970 --> 02:11:33.900
Markus Goese: Thanks a lot to read, thank you very much, my second question goes to the regulators and maybe we start with Maria and then, if you use would also be very much appreciated so question number two is.

02:11:34.800 --> 02:11:47.970
Markus Goese: What mechanisms are regulators utilizing during the code 19 pandemic to support a timely dialogue with industry with manufacturers as well as repartee provide manufacturers with scientific advice on.

02:11:48.660 --> 02:11:54.780
Markus Goese: Post approval changes so specifically on possible with changes and Maria first and then, if possible, if Tokyo.

02:11:57.450 --> 02:12:06.060
Maria Baca-Estrada: Thank you, I think that we have already mentioned the importance of the dialogue with with the industry in terms of.

02:12:07.230 --> 02:12:22.470
Maria Baca-Estrada: You know planning of what is going to be submitted as post approval changes, one thing that we have constantly been doing is requesting manufacturers to provide and to share with us the questions that have been also.

02:12:23.610 --> 02:12:32.250
Maria Baca-Estrada: Post by other regulatory agencies in order for us to not duplicate the work and enhance our ability and our timelines for the PR review.

02:12:32.940 --> 02:12:41.130
Maria Baca-Estrada: The same goes to our ability to communicate, we asked permission to communicate with other regulatory agencies with that same idea.

02:12:41.460 --> 02:12:52.710
Maria Baca-Estrada: of streamlining and ensuring that we don't duplicate the work that has already been done by others, I think that those mechanisms have been very important for us and we.

02:12:53.340 --> 02:13:06.240
Maria Baca-Estrada: really look forward as a as a way of, hopefully, little by little, being able to to have more of a work sharing and then you know, in the end, maybe some reliance initiatives, thank you.

02:13:07.740 --> 02:13:09.180
Markus Goese: Thanks Maria or Tokyo.

02:13:12.120 --> 02:13:18.960
Evdokia Korakianiti-EMA: Thank you, my question indeed sin, not what Maria described in addition.

02:13:20.940 --> 02:13:32.700
Evdokia Korakianiti-EMA: We will compost approval sentence even prior approval i've mentioned a couple of cases where we had discussed it with through rapid scientific advisors and over be the push marketing and.

02:13:33.300 --> 02:13:43.980
Evdokia Korakianiti-EMA: Compatibility approaches and authentic approaches to stability, but of course we're not limited to the marketers radiation and their opportunities, also to have collaborative scientific.

02:13:45.240 --> 02:13:51.990
Evdokia Korakianiti-EMA: advisors between regulators and are certain parts of Africa, working with can elaborate further.

02:13:53.460 --> 02:13:58.200
Evdokia Korakianiti-EMA: We have multiple interactions to the other teams that the industry and I mentioned, even before.

02:13:59.280 --> 02:14:02.490
Evdokia Korakianiti-EMA: Post approval weekly that's portion of supply plans.

02:14:04.080 --> 02:14:18.240
Evdokia Korakianiti-EMA: it's true that when I hear from a from industry and discuss and also from our perspective, he has put a lot of strain to the network yeah all these interactions and, yes, of course, there are more opportunities for beating covert and.

02:14:20.520 --> 02:14:21.630
Evdokia Korakianiti-EMA: Amongst regulators.

02:14:23.820 --> 02:14:35.970
Evdokia Korakianiti-EMA: Take thinking that post approval, the changes need to be submitted and approved rapidly and my passion of you would be, we need to start working towards collaborative assessment and also the missile.

02:14:36.480 --> 02:14:52.770
Evdokia Korakianiti-EMA: marketization collaborative assessment of protocols, like the PC and peace and within facilitate with Sammy Sosa data harmonize and first implementation across regions, perhaps one of the ways forward with unexplored Thank you.

02:14:53.640 --> 02:14:54.480
Markus Goese: Thank you for Tokyo.

02:14:55.710 --> 02:15:03.270
Markus Goese: My next question is again for industry, colleagues, so maybe tell your theory and also diane if you could, if you could give us your views on that so.

02:15:03.690 --> 02:15:10.530
Markus Goese: The question would be about regional differences and the regional differences with respect to managing post approval changes.

02:15:11.460 --> 02:15:17.340
Markus Goese: And from your top of mind what would you see as the biggest immediate term priority with respect to lifecycle management.

02:15:17.670 --> 02:15:27.750
Markus Goese: So maybe carrie if you could start with a challenge about regional differences and and to re enter this orientation, if you could then compliment with the opportunities that would be great.

02:15:29.580 --> 02:15:32.550
Thierry Gastineau: I feel that i'm an expert of challenges, more than.

02:15:34.620 --> 02:15:46.290
Thierry Gastineau: So something with the challenges so yeah yeah I mean, as I already said, I mean there are actually still a lot of original am more than original let's say local, national.

02:15:46.710 --> 02:15:54.990
Thierry Gastineau: Differences in the Trojan it, so we need to recognize and acknowledge the strong efforts actually that regulators have invitations for a number of.

02:15:55.380 --> 02:16:01.050
Thierry Gastineau: Instances actually to try to foster more harmonization convergence and actually, as you said, they have no channel.

02:16:01.380 --> 02:16:10.530
Thierry Gastineau: For collaborative approaches, but still I mean what we observe and Jen would comment on that i'm pretty sure we still observe, I mean actually number of differences local differences.

02:16:11.100 --> 02:16:24.450
Thierry Gastineau: My earlier, you said just before you reiterated, for example, the case of different specifications so So yes, that's that's that's the true life and, and so this is creating some issues, indeed, because.

02:16:25.140 --> 02:16:31.620
Thierry Gastineau: Despite the fact that as as our colleagues from Pfizer indicated you submit a single dossier to all countries.

02:16:31.920 --> 02:16:38.190
Thierry Gastineau: The outcome is not what are not always I mean having the same set of specifications at the end.

02:16:38.550 --> 02:16:51.930
Thierry Gastineau: And that, then at the end of the day, this is creating an issue, because actually with different specifications, while the product is manufactured in the same way, I mean, in some instances, you need potentially to reject some batches.

02:16:53.010 --> 02:17:00.510
Thierry Gastineau: For some countries, whereas it is OK for other countries also this may haven't seen any pattern stability or or chef wise, for example.

02:17:00.870 --> 02:17:13.530
Thierry Gastineau: So So yes, number of challenges if we are not converging and finding actually a, and this is back to the global approach, so this is, this is the main challenge again so i'll leave it to john for for potential.

02:17:15.450 --> 02:17:24.840
Diane Wilkinson: Thanks Terry and yeah i'm a great believer in you know if we've identified that as an issue, and I think we've identified this morning that's huge amount of fantastic work and flexibility is applied.

02:17:25.320 --> 02:17:28.320
Diane Wilkinson: Through negotiation between industry and and regulators.

02:17:29.010 --> 02:17:38.370
Diane Wilkinson: But opportunities there to improve this even further and certainly in applying some of the science based and risk based approaches that we've heard about from a technical perspective.

02:17:39.060 --> 02:17:45.120
Diane Wilkinson: And the globalization, I think, very importantly, I think, as has been said, you know that the pandemic is still ongoing.

02:17:45.480 --> 02:17:58.560
Diane Wilkinson: There are still many millions of patients who are still waiting to be vaccinated so there's work that we can still do together to build an improvement still on how we can manage both them as and lifecycle management.

02:17:59.880 --> 02:18:05.430
Diane Wilkinson: It is about overcoming those national barriers and an example, you know we can give of those is that there are still some agencies.

02:18:05.730 --> 02:18:12.870
Diane Wilkinson: Insisting that you know we can only apply one lifecycle management change at a time, while that's being reviewed so those sorts of national.

02:18:13.740 --> 02:18:28.590
Diane Wilkinson: requirements need to be overcome, and we need to work together to do that, and maybe some of the agencies who are represented today, you know can can talk widely about their best practice and make sure that that does get to a wider group than even outside of the admiralty.

02:18:30.000 --> 02:18:39.240
Diane Wilkinson: What we'd like to see is you know they're our examples out there of where harmonization has worked even do this pandemic, you know I think many companies as ED and Pfizer and others have had.

02:18:39.690 --> 02:18:45.810
Diane Wilkinson: My experience through the WHO emergency use procedure where approval through an s ra.

02:18:46.590 --> 02:19:00.000
Diane Wilkinson: Has then been approved by the WHO in five to 10 days and then that is put onto a source of information, which certainly speak to a dedication at seven different markets, then access and apply.

02:19:00.420 --> 02:19:05.790
Diane Wilkinson: Generally, without question, and that's worked incredibly well and, for me, as an example of.

02:19:06.090 --> 02:19:20.880
Diane Wilkinson: You know if we've got the same science which we're all taught in schools, globally, the same science, the same product, then we should be able to achieve in a pandemic situation, the same science risk based review and that's a challenge, I think, for all of us to continue to work on.

02:19:22.350 --> 02:19:25.680
Markus Goese: Thanks diane Thank you very much, I have a question for you, though, young.

02:19:26.580 --> 02:19:34.020
Markus Goese: On the opportunities so maybe and that's a question actually where I would also like to hear back from from our colleagues from regulatory agencies.

02:19:34.260 --> 02:19:43.710
Markus Goese: So talking about opportunities can you maybe describe a bit more in detail a positive experience you've had during the pandemic regarding the use of was very specific lifecycle management tool.

02:19:45.480 --> 02:19:53.190
Diane Wilkinson: yeah please to Marcus because there's been many positives now we're talking about some of the challenges and opportunities but there's been many positives and we should build off those.

02:19:53.820 --> 02:20:02.640
Diane Wilkinson: So he said a certainly submitted post approval change management protocols in our example that was.

02:20:03.270 --> 02:20:14.550
Diane Wilkinson: reviewed prior to submission and agreed almost as a protocol and then accepted by the AMA and that meant that for adding drug substance and drug product sites that that was.

02:20:14.820 --> 02:20:22.230
Diane Wilkinson: reduced from a category of type two through to what was called a Type one be accelerated and remarkably you know, due to the.

02:20:22.770 --> 02:20:38.700
Diane Wilkinson: Herculean efforts of industry and agency that meant that we were having approvals for adding site within five to 10 business days and that's a huge reduction from the general 60 days and an ongoing dialogue, even within that time frame so great.

02:20:39.690 --> 02:20:46.740
Diane Wilkinson: Achievement there and to add to that you know that was then accepted by a number of other agencies following review with the AMA.

02:20:47.340 --> 02:20:57.240
Diane Wilkinson: Without further question, and that was great to see that application there and that's been allowed to again to add sites health Canada, been an example am hra being another example.

02:20:57.810 --> 02:21:04.260
Diane Wilkinson: And we've had a huge increase in over 25 CMOs and test sites added through that.

02:21:04.950 --> 02:21:11.700
Diane Wilkinson: we've also you know where that wasn't allowed, because what was often quoted to us was you know case MPs will not be allowed to and through national legislation.

02:21:12.120 --> 02:21:22.230
Diane Wilkinson: Again that's a problem to me and it's got to be a solution, so they asked there was that you know could agencies, therefore, speed up what was their normal process and again we saw great.

02:21:22.770 --> 02:21:33.120
Diane Wilkinson: Use of that through countries like Argentina and Brazil and Thailand, where they were committing to approve any of the changes within the 30 day period.

02:21:33.810 --> 02:21:41.520
Diane Wilkinson: So be great to think that we could increase that and maybe this is an opportunity as as Greg mentioned here we have the icmp is described in Q 12.

02:21:41.970 --> 02:21:55.650
Diane Wilkinson: This really is an opportunity for us to not go off in divergent ways, but really apply Q 12 and the tools within it's just being a Sam bees on a global basis and make sure we are being consistent in how that is being applied.

02:21:56.790 --> 02:22:05.430
Markus Goese: Thanks diane um let me be a bit reverse the order of our panelists now maybe because I said I would be interested in the views from the regulatory agencies, maybe Mohammed.

02:22:05.940 --> 02:22:15.780
Markus Goese: And, and then refaeli could you share any any views you have on the use of force, the proper change management protocols, or even expanded also probably change management protocols, maybe Mohammed first.

02:22:18.660 --> 02:22:20.670 yeah Thank you Marcus.

02:22:21.810 --> 02:22:30.060 Well, again, we understand that in such a public health emergency not everybody will be able to provide all information and.

02:22:31.980 --> 02:22:35.940 Follow the corporate calls and provider requirements on time so.

02:22:37.890 --> 02:22:43.830 For pitching so we have seen cases where what cause will not provide it, but again.

02:22:45.090 --> 02:22:53.580 As my colleague stated it's a risk based decision making process and we, we had to do with what we had a time.

02:22:54.690 --> 02:22:55.110

02:22:57.660 --> 02:23:02.760
Markus Goese: Thank you, thank you, Mohammed, thank you very much, Raphael any us from an investor perspective.

02:23:03.180 --> 02:23:19.560
Raphael Pereira: Oh yes, actually, we do not have a formal posts are probably change management protocol, yet, but we we use it, it unfortunately at some cases during the pandemic actually it's it's.

02:23:20.700 --> 02:23:23.370
Raphael Pereira: it's a big challenge to implement this kind of.

02:23:24.660 --> 02:23:35.010
Raphael Pereira: To during a pandemic, but we use it it informally in some cases, and we plan to have a pilot to formal implementation of PAC and be.

02:23:36.330 --> 02:23:48.630
Raphael Pereira: Very soon, so we, this is an internal discussion we understand it's an important to four to to manage the post approval changes, as I said, in this case.

02:23:49.260 --> 02:24:06.630
Raphael Pereira: We need to look at PAC less as work and more as an opportunity, but it's it's also a challenge to discuss a case by case basis, so PCP is, it should be an important to in order to have a.

02:24:07.740 --> 02:24:10.620
Raphael Pereira: discussion that is as general as possible.

02:24:11.790 --> 02:24:21.510
Raphael Pereira: So we are planning to implement it formally as soon as possible, and we had use it and formally in some cases, during the pandemic.

02:24:23.040 --> 02:24:32.160
Markus Goese: Excellent great Thank you very much rafi I think we are almost approaching the end of our discussion here, unfortunately, because of the time limitation of the workshop.

02:24:32.520 --> 02:24:41.280
Markus Goese: I have one last question and and my my request would be for a very brief answer, but I have one more question for the regulators.

02:24:41.700 --> 02:24:46.170
Markus Goese: And then maybe if Tokyo, if you could start and then maybe Maria us would also be appreciated.

02:24:46.800 --> 02:24:54.510
Markus Goese: We have heard in the recent past, a lot about you know collaborative review initiatives like access and open project always answer on.

02:24:55.020 --> 02:25:07.860
Markus Goese: Has there been any considerations of such kind of initiatives, also in the post approval space, so not for initial marketing authorizations or emergency us, but for post approval variations of Tokyo, please, and then Maria.

02:25:09.960 --> 02:25:10.740
Evdokia Korakianiti-EMA: and

02:25:11.820 --> 02:25:20.310
Evdokia Korakianiti-EMA: Yes, what we have been doing so far is exchanging information and actually even a setting up the dialogue meeting as my post production.

02:25:20.640 --> 02:25:37.200
Evdokia Korakianiti-EMA: dial up meetings between associate to discuss key issues you like, for example, setting specific edge international and actually this goes into data will receive the data bucket is because i'm not always exactly the same, and in some cases, unfortunately we couldn't align because of different.

02:25:38.280 --> 02:25:58.050
Evdokia Korakianiti-EMA: legal framework for the at those particular cases, however, we haven't moved so far as going towards collaborative huge a I think comes very strongly out of this workshop that this is, these are important considerations, in my view such a collaborative reviews me to be on.

02:25:59.700 --> 02:26:04.950
Evdokia Korakianiti-EMA: A common baseline in the initial dossier and ideally.

02:26:06.780 --> 02:26:21.930
Evdokia Korakianiti-EMA: I believe, as in in need is a good starting point collaborative reviews of protocols, because once the strategies agreed, then the national employment data or the regional implementation becomes much faster and easier to implement in my experience.

02:26:25.080 --> 02:26:27.060
Markus Goese: I think for this Thank you have to kill Maria.

02:26:27.840 --> 02:26:37.410
Maria Baca-Estrada: Yes, I think this is this is going to be a great opportunity, I think that the work sharing initiatives that health Canada has been involved and have been.

02:26:38.130 --> 02:26:44.130
Maria Baca-Estrada: challenged by many, many issues, one in in terms of the debt, the deadlines that every every.

02:26:44.820 --> 02:27:07.380
Maria Baca-Estrada: story has for review timelines and and also the large type of files that have been used for this initiatives, however, for the post approval changes, I think it is a very good opportunity, because we can start this work sharing reliance type of initiatives with a small packages is small.

02:27:09.270 --> 02:27:18.660
Maria Baca-Estrada: files which will lead to maybe better and more interactive interactions internationally, especially for vaccines in the global.

02:27:18.930 --> 02:27:28.740
Maria Baca-Estrada: space, so I think that there is a lot of opportunities, we have not had yet me, but we are very much involved and and wanting to participate in this type of activities, thank you.

02:27:29.610 --> 02:27:30.960
Markus Goese: Excellent Thank you very much.

02:27:32.580 --> 02:27:34.470
Markus Goese: Yes, Jerry would you like to.

02:27:34.830 --> 02:27:48.510
Thierry Gastineau: I just would like to add that was not mentioned before, I think, because we are spending a lot about the lions just would like to remind also the devil show who the felines practices which has just been issued, very recently, but I think he should be a great to neighbor.

02:27:49.590 --> 02:28:01.830
Markus Goese: Absolutely, thank you very much Jerry on that note, unfortunately, I believe we have already reached the end of our panel discussion here, so I would like to thank all the panelists and with that hand over back to Mr Thank you very much.

02:28:02.910 --> 02:28:20.730
Emer Cooke: Thank you very much Marcus and I will immediately hand over to the array for the third and final panel session on X inspections old all tentative tools and very fittingly reliance practices again over to the rain, please.

02:28:21.660 --> 02:28:30.450
Lorraine Nolan: Thank you very much humor, and for that introduction and good morning Good afternoon, good evening and probably almost good night of the stage to all of you.

02:28:31.110 --> 02:28:40.590
Lorraine Nolan: Great leverage to be involved today and also to moderate this panel discussion, which is on alternative approaches to inspection.

02:28:41.010 --> 02:28:47.850
Lorraine Nolan: So just a couple of opening remarks for myself, I think it's probably fair to say that all organizations, whether you're based in industry.

02:28:48.210 --> 02:28:59.850
Lorraine Nolan: or you're based in Regulation have really undergone quite radical changes in terms of how we conduct our day to day activities with much of our day time now spent at working in remotely.

02:29:00.600 --> 02:29:09.210
Lorraine Nolan: And I suppose regulatory gsb inspections are an activity that we would typically associated as being an activity that has conducted onsite.

02:29:09.630 --> 02:29:19.710
Lorraine Nolan: Where we have close face to face observation of processes, but also really importantly I think grace a face to face interaction with personnel.

02:29:20.400 --> 02:29:30.330
Lorraine Nolan: So during the pandemic and it's definitely been touched upon, and it has come out during the earlier presentation, the case studies and also the panel discussions inspection itself has changed.

02:29:30.690 --> 02:29:41.610
Lorraine Nolan: Quite a lot in that time and we've seen significant use of alternative approaches from desktop reviews to remote this inspections blended approaches mutual reliance.

02:29:41.940 --> 02:29:52.830
Lorraine Nolan: And all sorts of combinations of the same so it's been a big adjustment for all of us, so I really think what is fantastic about this discussion is we get an opportunity for a bit of a deeper dive.

02:29:53.370 --> 02:29:59.370
Lorraine Nolan: And to really kind of discuss what has been the industry experience of those processes and those changes.

02:29:59.700 --> 02:30:07.530
Lorraine Nolan: and also the regulatory viewpoints as well, and maybe to think a little bit about future of inspections and what that may look like for us.

02:30:07.860 --> 02:30:14.340
Lorraine Nolan: So, again we have a great panel and with a mixture of individuals from vote regulation free and.

02:30:14.730 --> 02:30:26.550
Lorraine Nolan: backgrounds and industry background, so the regular she viewpoints great pleasure to welcome Brendan cody from em a dark Smith from FDA Muhammad again from Saturday FDA.

02:30:27.180 --> 02:30:36.390
Lorraine Nolan: and pull a Walker from UK and he Ray and then from industry, we have Stephen Mandeville amgen Caroline bell from kingdom.

02:30:36.960 --> 02:30:49.950
Lorraine Nolan: Drug delivery and Dr G decide from duping so and one thing I will say we have a lot of questions to get through and i'm very keen to draw out both the industry perspective on the regular Adrian perspective on these.

02:30:50.340 --> 02:30:58.530
Lorraine Nolan: So i'm going to apologize, in advance, because I think this question session for the panelists is going to feel a little bit like a rapid speed dating so i'm going to be.

02:30:59.580 --> 02:31:06.810
Lorraine Nolan: Across on the time and keeping to us, so my first question I think we'll go to the regulatory perspective so to pull up.

02:31:07.410 --> 02:31:14.370
Lorraine Nolan: And it is a point I think that was raised by Connie and one of the earlier presentations this morning and it relates very much so, to terminology.

02:31:14.850 --> 02:31:23.760
Lorraine Nolan: So we use the terms remote inspection distance inspection desktop inspection virtual respect runs under used by us interchangeably as regulators.

02:31:24.360 --> 02:31:36.360
Lorraine Nolan: Either the same that's My first question to you either subtle differences and then reflecting on the experience of the last number of months, how do you think what we have been true will change the approach for the future.

02:31:36.870 --> 02:31:41.280
Lorraine Nolan: So Paul, it will get you maybe to turn on the camera and respond to that question.

02:31:42.570 --> 02:31:44.760
Paula Walker: Is Lorraine, can I just check that you can hear me.

02:31:44.760 --> 02:31:45.300
Lorraine Nolan: I can.

02:31:45.720 --> 02:31:54.180
Paula Walker: enter and science, that I think it's a really interesting question and i'm speaking today with my hat on as the.

02:31:54.690 --> 02:32:01.710
Paula Walker: Chair of the ecommerce digital inspections working group that covers tcp and GNP, so I think first of all.

02:32:02.100 --> 02:32:07.530
Paula Walker: I think it's important to say that what we've seen over the last 18 months of, as you just alluded to.

02:32:07.800 --> 02:32:18.030
Paula Walker: In the pandemic innovation across all regulators to enable inspections to facilitate the supply the quality and patient safety has has been incredible to see.

02:32:18.390 --> 02:32:27.150
Paula Walker: And it wouldn't surprise you to know that the definitions of the types of inspections has generated a lot of discussion in the current digital inspections record brief as well.

02:32:27.510 --> 02:32:33.090
Paula Walker: Particularly as the group covers both tcp and dmv as well, so lots of differences there.

02:32:33.570 --> 02:32:45.720
Paula Walker: And so, as you said, there are a variety of terms that are used, but I think essentially what we're looking at is on site inspections, which of course we're all very familiar with it and do what they say.

02:32:46.080 --> 02:32:56.820
Paula Walker: And then we have the remote distant virtual inspections which, again, I think we can greet together as all being essentially the same thing, which is the process of conducting inspections.

02:32:57.120 --> 02:33:10.020
Paula Walker: and evaluations or assessments at a distance so virtually and that could be supported by technology for communicating for sharing documentation for seeing things if it's visual technology.

02:33:10.230 --> 02:33:18.000
Paula Walker: Accessing systems remotely etc, without the inspectors being physically present on site, as they would have been pre pandemic.

02:33:19.170 --> 02:33:29.430
Paula Walker: And then we also have hybrid inspection so just to throw in an additional 10 there, which is a mix of the two and we've used a lot of that over the last 18 months as well.

02:33:30.300 --> 02:33:42.660
Paula Walker: I think one of the important things to highlight as well around inspections is that throughout the pandemic ignorant has recommended the effective cooperation among global partners to ensure that any changes that are implemented within the inspection programs.

02:33:42.930 --> 02:33:48.480
Paula Walker: have enabled continued confidence in the ability to rely upon the exchange of compliance information.

02:33:48.810 --> 02:33:53.340
Paula Walker: Under both collaborative agreements and arrangements mutual reliance initiatives.

02:33:53.640 --> 02:34:02.160
Paula Walker: And the type of inspection approaches always considered in relation to those initiatives, and I know that's generated quite a lot of discussion over the course of the session today.

02:34:03.030 --> 02:34:10.020
Paula Walker: So I think that probably covers off the terms question, hopefully, and so on your second question, in terms of.

02:34:10.350 --> 02:34:13.440
Paula Walker: What we can expect to see looking forward in the future.

02:34:13.650 --> 02:34:25.860
Paula Walker: Again that's generated a lot of discussion in the group and the focus of the camera group at the moment is very much to reflect on the experience that's been gathered to date by regulators in terms of inspections during the pandemic.

02:34:26.670 --> 02:34:38.340
Paula Walker: I think moving forward as a variety of us from the regulators in the group in terms of future approaches, but I think it's fair to say as a summary that will see a mix of hybrid approaches moving forward so.

02:34:38.670 --> 02:34:42.570
Paula Walker: A combination of on site and also remote inspection activity.

02:34:42.990 --> 02:34:57.150
Paula Walker: And that will continue, depending on the product, depending on the requirements of the inspection to really ensure the most effective approach to public health and efficient focus use of resources, as well, both from an inspector, and also from an industry perspective.

02:34:58.380 --> 02:35:06.600
Lorraine Nolan: Thanks okay Paula Thank you very much for those insights so i'm going to move with this team on questioning about the future of inspections and maybe.

02:35:06.960 --> 02:35:12.360
Lorraine Nolan: Put it to all three of our industry colleagues to to ask you what your perspective of.

02:35:12.780 --> 02:35:25.440
Lorraine Nolan: The changing inspection tools we have been using during the pandemic and what that has been like for industry and maybe how you would like to see things moving forward as well, so if we might go first of all to regime and we bring you in there.

02:35:26.460 --> 02:35:28.380
Lorraine Nolan: Thank you so much Kelly.

02:35:28.770 --> 02:35:36.210
Rajiv Desai: And I think the last 18 months months have been quite interesting and it's been a learning experience for all of us.

02:35:36.690 --> 02:35:46.590
Rajiv Desai: And, as you know that the film industry has been categorized as essential services so not a day has been no wasted in the manufacturing sites.

02:35:47.040 --> 02:35:55.920
Rajiv Desai: At the same time, we have seen a lot of these remote inspirations the virtualization is there a distance the desktop inspiration, as they keep on turning it.

02:35:56.400 --> 02:36:04.140
Rajiv Desai: And I think the industry has been kept busy many of the regulatory agencies coming and performing these kind of inspections.

02:36:04.620 --> 02:36:14.700
Rajiv Desai: And I think our experience has been quite good, we learned a lot during the last couple of months time, and we have perfected the technique of increasing the inspections, this new.

02:36:15.750 --> 02:36:23.220
Rajiv Desai: mode of new channel that we may call it, and of course we missed the dental excitement of having physical inspections.

02:36:23.640 --> 02:36:34.980
Rajiv Desai: The investigators also have shown and also indicated that they missed the entire excitement of traveling all the way to the country to different countries and see and talk to the people.

02:36:35.520 --> 02:36:47.160
Rajiv Desai: But I would say that the inspections have been done in a very serious manner, we have been able to demonstrate the ability to meet the standards of the quality.

02:36:48.060 --> 02:37:03.510
Rajiv Desai: And we have faced it very well, I think you talk about tg a DMA HP era, who image sorry FDA you name it and I think we have a great experience with all these agencies in the last couple of months time even.

02:37:03.990 --> 02:37:07.920
Rajiv Desai: Just a couple of days back, we finished our image our inspection also one of the site.

02:37:08.490 --> 02:37:18.600
Rajiv Desai: And they really appreciated the way the virtual and the live video demonstration or the life of beaming was done or from the manufacturing sites.

02:37:18.990 --> 02:37:28.650
Rajiv Desai: And they asked for the technology that we used, and it was quite nice to know that today I appreciate the full technology that has been.

02:37:29.160 --> 02:37:37.710
Rajiv Desai: used for these kind of virtual inspections, and I think these will continue, even if the pandemic goes away, I think we have.

02:37:38.220 --> 02:37:54.120
Rajiv Desai: We know the advantages of such inspections, there will be a hybrid way of performing inspections in the future and the industry is ready for that we save a lot of time, but the same time, the quality of inspirations continue to be at a very high level, thank you.

02:37:55.230 --> 02:38:02.400
Lorraine Nolan: Thank you very much reggie I have to say in 20 years of working in regulation is the first time that anyone has ever told me they got excited it's just.

02:38:03.030 --> 02:38:16.530
Lorraine Nolan: An inspection so very good to hear, so I will move that question to Caroline just to give some perspectives from your point of view, in terms of the industry's experience with remote inspections and how you see the future evolving as well well.

02:38:16.740 --> 02:38:23.490
Caroline Bell: Hello everyone, and yes, similar to reggie we've had a number of inspections over the last year or so.

02:38:23.760 --> 02:38:34.140
Caroline Bell: And we've had a combination, or what I would say is remote desktop inspections, where we share low a lot of documentation electronically, and we have with us via email.

02:38:34.470 --> 02:38:39.570
Caroline Bell: We had more the virtual inspection where we're on a teams or zoom call with the inspector.

02:38:39.900 --> 02:38:50.220
Caroline Bell: And then we've also had and with me cherry actually a more of a hybrid inspection, where it was pouch and desktop review and then power to other folks as well, which was.

02:38:50.640 --> 02:38:56.310
Caroline Bell: The first form sales orders we've had since the start of the pandemic and I think.

02:38:56.880 --> 02:39:05.370
Caroline Bell: As we've evolved we've gone from being quite and obviously new to everything and getting the technology to work has been challenged in some instances.

02:39:05.820 --> 02:39:15.390
Caroline Bell: And, but I think as times gone on and we've evolved it's been good we've had the opportunity to work closely with the inspectors and things have been proved us as inspections have gone on.

02:39:15.780 --> 02:39:26.670
Caroline Bell: we've certainly got more creative with the way we've been able to share documentation and also obviously one big limitation of a virtual inspection is the inspector not physically being able to see the plant.

02:39:27.090 --> 02:39:37.680
Caroline Bell: So for for one inspection, we did actually end up bringing up an iPad on a trolley and pushing it around cancer that the inspector could could see you know live virtual.

02:39:38.040 --> 02:39:45.840
Caroline Bell: And we've also used videos of key processes and things, so I think as time evolved and we've got more.

02:39:46.440 --> 02:39:58.080
Caroline Bell: slick at using the technology and to capitalize it and maximize on the amount that we can share with the inspector, because that is one of the big limitations of that kind of inspection, so I think in terms of.

02:39:58.950 --> 02:40:06.660
Caroline Bell: What we've been able to provide the inspectors received several been able to still demonstrate our compliance we've still been able to give the inspector.

02:40:06.990 --> 02:40:22.530
Caroline Bell: And the the right information and the right feel about the facility, so I think in general, given how trepidations we were to begin with, I think we're now at the stage where and we're much more adapted to it and we've set up and more technology to support us.

02:40:23.670 --> 02:40:31.050
Lorraine Nolan: Thank you very much for that Caroline and Stephen will give you the opportunity as well to to give your perspective on that question so it's Nice.

02:40:31.620 --> 02:40:39.000
Steve Mendivil: Thanks to Ray it's been great to see regulators adopt and use these alternative tools for onsite inspections during the pandemic.

02:40:39.390 --> 02:40:47.400
Steve Mendivil: And as we've all seen these have been critical during covert and they should continue to be utilized after the pandemic is behind us.

02:40:47.910 --> 02:40:57.480
Steve Mendivil: However, specific tools and their terminology seems to vary by region, it should be important to develop some type of a universal toolbox.

02:40:57.810 --> 02:41:04.680
Steve Mendivil: Of these alternative tools really at a policy level to gain a better global understanding and alignment.

02:41:05.580 --> 02:41:14.190
Steve Mendivil: at an operational level, no matter what tool you use it's been my experience it's important to mimic as much as possible.

02:41:14.520 --> 02:41:21.270
Steve Mendivil: On on site inspection with real time discussions and questions, allowing faster assessment and understanding.

02:41:21.840 --> 02:41:38.310
Steve Mendivil: We found that document review based alternative tools that don't utilize real time dialogues they're not as efficient and effective for both parties and, in our experience these assessments can drag on for weeks or months and it's not a good use of resources.

02:41:40.350 --> 02:41:49.590
Lorraine Nolan: Okay, thank you very much Steve and my next question and i'm going to go to the regulatory perspective on this first of all, and then we'll come back it's.

02:41:49.950 --> 02:41:54.240
Lorraine Nolan: And it has come out in some of the answers to the first question, and it relates to.

02:41:54.660 --> 02:42:06.990
Lorraine Nolan: The limitations and the application of remote xp inspections and twice so maybe if I could bring in Mohammed here at this point and Muhammad let you perhaps give some practicing reflections on that question.

02:42:09.660 --> 02:42:18.240
Mohammed Alageel, SFDA: Yes, thank you reena taken to the customization the advantage of the importance of shape as offensive word.

02:42:19.620 --> 02:42:34.770
Mohammed Alageel, SFDA: For the scientist, which is especially during this circumstances and with the 19th endemic, yes, there is some challenges and a limitation and the application of 30 more construction budget speed.

02:42:36.060 --> 02:42:42.810
Mohammed Alageel, SFDA: So some of we can mention some of them like the availability of that technology.

02:42:43.830 --> 02:42:54.510
Mohammed Alageel, SFDA: Some of the companies can I be able to provide the necessary required tools to perform the remote inspection, for example, they cannot be able to have.

02:42:54.990 --> 02:43:04.830
Mohammed Alageel, SFDA: A good connection for Internet or the donut have a camera, so we cannot make the the inspection festival other point is.

02:43:05.520 --> 02:43:26.790
Mohammed Alageel, SFDA: Are the older side suitable to perform the rewards inspection, as some some manufacturing, like the biological sites or the side, providing the service projects with a separate process process technology, not be easy to access some areas on those sites.

02:43:28.290 --> 02:43:38.700
Mohammed Alageel, SFDA: And then another point, like the time zone difference, so one of the important issues need to be considered if you want to do the inspection remotely.

02:43:40.080 --> 02:43:49.080
Mohammed Alageel, SFDA: One the last point, maybe the the ability to share the documents that may requested from the spirit of during the description.

02:43:49.470 --> 02:43:55.650
Mohammed Alageel, SFDA: Because, as you know, some of the documents requested during the especially need to be discussed and.

02:43:56.220 --> 02:44:12.090
Mohammed Alageel, SFDA: diffused by then spoke to during the inspection, so the company, maybe not be able to provide with the same time, or it may take a long time, this is maybe some point, a to be considered i've worked with industry to solve that, in future, but to live in.

02:44:13.050 --> 02:44:23.640
Lorraine Nolan: Okay, thank you, Mohammed and Caroline I know in your answer to the question I just gave you there are a few moments ago, you did touch upon some limitations, I just want to give you the opportunity, maybe.

02:44:24.030 --> 02:44:28.680
Lorraine Nolan: If there are a few more than mutations to the process that you have observed as well, so i'll come back to you.

02:44:29.280 --> 02:44:43.020
Caroline Bell: yeah I mean, obviously, the main one is not being able to physically show the inspectors, that the site and especially when you've got complex processes or it's an inspector that isn't familiar with the with the site or product type.

02:44:43.560 --> 02:44:54.390
Caroline Bell: and obviously we've employed different technologies to help with that, but that that has its limitations in itself when you've got quite intricate processes that work in terms of the manufacturing and in particular the lab testing as well.

02:44:55.020 --> 02:45:01.440
Caroline Bell: And what we've also found, as well as in terms of sharing documents when it's when it's a purely desktop inspection.

02:45:02.190 --> 02:45:11.580
Caroline Bell: were receiving questions by email, and you don't get the richness of the discussion and that you would get obviously in a face to face or even with a with a virtual inspection.

02:45:11.940 --> 02:45:21.360
Caroline Bell: Some documents lend themselves more easily to that type of inspection when it's standard so PS, or you know standards and quality manuals things like that, but when you've got.

02:45:21.720 --> 02:45:31.260
Caroline Bell: complex and procedures or work instructions that you really need to be put into context with the process and that can be quite limiting and it, I think it has.

02:45:31.650 --> 02:45:41.370
Caroline Bell: led to us getting perhaps observations that we wouldn't necessarily have had, have you been able to put the procedure in context with the with the process.

02:45:42.300 --> 02:45:48.720
Caroline Bell: And I think as well, what we what we tend to get with some of the the desktop inspections is I think Steve mentioned, they can end up.

02:45:49.680 --> 02:45:52.590
Caroline Bell: Lasting for a lot longer than you would normally have a.

02:45:53.220 --> 02:46:09.090
Caroline Bell: An on site inspection, because it does take many, many days you know you're presenting the inspector, with potentially hundreds of documents via a team's channel or electronic means, and that can mean that it's it can be quite a protracted process for for both sides yeah.

02:46:09.600 --> 02:46:18.360
Lorraine Nolan: Lots of nodding heads are correct hardline agreeing with that statement there as well, too, so my next question and I was an inspector myself many years so.

02:46:18.630 --> 02:46:27.180
Lorraine Nolan: It is something that interesting very much and then it is the culture of companies, so in remote or a virtual environment and.

02:46:27.990 --> 02:46:43.050
Lorraine Nolan: How is the best to SAS so it's am talking here about you know how the culture of quality is promoted within a company so maybe directly if we could call you in at this point, and just ask you what your observation on this has been from the regulatory viewpoint so Derek over to you.

02:46:44.010 --> 02:46:53.970
Derek Smith, US FDA: Thanks during yeah and and, interestingly enough i'm The co chair for the new inspection protocol project at the FDA, and this is a topic that was sort of introduced into the surveillance inspection Program.

02:46:54.510 --> 02:47:01.530
Derek Smith, US FDA: In 2019 when it sort of launched, and so I agree with you it's an interesting area it's foundational to a facility.

02:47:02.010 --> 02:47:11.430
Derek Smith, US FDA: it's really driven by management management commitment to quality and so those aspects you know mature quality culture that we look for investing in people.

02:47:11.760 --> 02:47:18.510
Derek Smith, US FDA: Establishing organizational objectives that drive quality quality system that shape culture, focusing on innovation and continual improvement.

02:47:19.050 --> 02:47:27.990
Derek Smith, US FDA: Moving to performance based quality management having a robust metrics program, with a focus on analytics and including risk management plans and forecasting to ensure reliability of the supply.

02:47:28.560 --> 02:47:34.950
Derek Smith, US FDA: And do some of these indicators are not very easily observed during a remote sensor action.

02:47:35.910 --> 02:47:41.340
Derek Smith, US FDA: But we certainly can see the records the records that we review and some of the interviews that we conducted on you know.

02:47:41.610 --> 02:47:46.050
Derek Smith, US FDA: During these remote evaluations that we let we can leverage that information and sort of provide.

02:47:46.410 --> 02:47:56.460
Derek Smith, US FDA: Evidence of little pieces of the quality practices of the facility that really show the maturity of the culture and so that's what we're looking for in those you know documentation and reviews and requests.

02:47:57.600 --> 02:48:05.040
Lorraine Nolan: Thank you very much for that insight as well, and it is true it's it's less tangible in there, and there are most environments so Steve.

02:48:05.460 --> 02:48:17.100
Lorraine Nolan: Maybe passed to you just to ask from a company's perspective when you are the subject of remote inspection, what is the best way to represent the company's culture and focus on quality.

02:48:18.660 --> 02:48:28.440
Steve Mendivil: yeah thanks for rain, I think we fully support regulators as testing quality culture and quality maturity and would love to see these assessments utilize the support.

02:48:28.830 --> 02:48:36.360
Steve Mendivil: Really, an enhanced risk based inspection scheduling and support regulatory flexibility for those high performing sites.

02:48:36.870 --> 02:48:46.290
Steve Mendivil: However, I don't believe regulators have adopted a formal evaluation tool for quality culture or quality maturity yet and, in my experience.

02:48:46.680 --> 02:48:53.640
Steve Mendivil: As the leader of the PDA quality metrics and cold horticulture Task Force it's important to develop a tool.

02:48:54.000 --> 02:49:03.180
Steve Mendivil: That assesses mature system attributes that correlate with positive quality culture behaviors right you got to have that correlation.

02:49:03.660 --> 02:49:07.500
Steve Mendivil: We developed an assessment tool based on 21 mature system attributes.

02:49:08.070 --> 02:49:25.830
Steve Mendivil: But assessing these attributes is not just reviewing documents, but rather it's interviewing and having discussions with shop floor staff and assessing whether these mature attributes had been fully socialized down into the organization and are being used this is.

02:49:26.880 --> 02:49:36.510
Steve Mendivil: In 2018 PDA launch the tool train both industry and regulators, we have not tried the assessments remotely yet.

02:49:37.020 --> 02:49:45.990
Steve Mendivil: But with the current technology, I believe this could be done successfully regarding how a company could best represent its culture during an inspection.

02:49:46.680 --> 02:49:59.010
Steve Mendivil: It may be difficult until regulators adopt some type of testament assessment tool standard right, so we have a common language and a common understanding around quality culture, for example.

02:49:59.670 --> 02:50:03.570
Steve Mendivil: A site could say, well, we do quality culture assessment surveys annually.

02:50:04.020 --> 02:50:16.710
Steve Mendivil: But without a common understanding with regulators, on which mature attributes are being assessed and which correlate the positive behaviors it doesn't have much meaning and because we don't have the language or measurement tool.

02:50:17.250 --> 02:50:23.520
Steve Mendivil: to represent how successfully, we are driving continuous improvement of our quality culture.

02:50:24.630 --> 02:50:36.630
Lorraine Nolan: it's an evening, thank you very much Steve again I think some fantastic reflections there and brandon I have a question for you and it very much so echo some of the questions that are coming in through the Q amp a on.

02:50:37.050 --> 02:50:48.690
Lorraine Nolan: Inspection capacity, and it is a major challenge in terms of inspection resource for for regulators also challenging I guess for industry to to resource inspections and go to acknowledge that.

02:50:49.080 --> 02:51:04.320
Lorraine Nolan: So do you think brandon that remote inspections have the potential to increase overall capacity are do you think there is a potential for to seeing issues like maybe the frequency at which inspections may be conducted changing so brandon over to.

02:51:08.910 --> 02:51:10.050
Lorraine Nolan: Seeing brandon.

02:51:12.930 --> 02:51:14.550
Emer Cooke: I see him, but he seems to be.

02:51:14.580 --> 02:51:15.540
Steve Mendivil: No, we can't hear you.

02:51:16.260 --> 02:51:18.210
Lorraine Nolan: know your needs your own you.

02:51:19.740 --> 02:51:20.820
Steve Mendivil: know them you.

02:51:24.810 --> 02:51:39.540
Lorraine Nolan: Okay, well, I think, just to keep the dialogue going i'm just going to push to maybe one of my regulatory colleagues, because the question is on inspection capacity from the regulatory viewpoints that Derek apologies that put you on the spot.

02:51:40.740 --> 02:51:43.680
Lorraine Nolan: But maybe if you could maybe give some perspective on that.

02:51:45.300 --> 02:51:46.080
Derek Smith, US FDA: Yes, certainly.

02:51:49.380 --> 02:51:56.730
Derek Smith, US FDA: we've seen is that the Ramon inspections can often be even more resource intensive and then i've been admitted remote interaction.

02:51:57.840 --> 02:52:09.630
Derek Smith, US FDA: is more intensive than an onsite inspection and said, so I think that's really some things that we have to look at moving forward is how do we, how do we utilize the of the the.

02:52:10.770 --> 02:52:19.140
Derek Smith, US FDA: interactions and assessments to from a resource capacity to be more efficient right so So is there is there an avenue to streamline some of the records.

02:52:19.650 --> 02:52:25.950
Derek Smith, US FDA: request that we use to then focus resources differently on the inspection but also just be cognizant of the amount of time.

02:52:26.460 --> 02:52:39.810
Derek Smith, US FDA: You know, from both I think the regulator side and the industry side in putting together the documents that we requested and also reviewing the documents um, so I think there is definitely a restart increase the resource use for these remote evaluation so far.

02:52:40.800 --> 02:52:49.950
Lorraine Nolan: yeah I would say that has been one of the real learnings I think part of the experience over the past, while is that often you think you gain efficiencies in one way, but it turns out to be.

02:52:50.550 --> 02:53:00.390
Lorraine Nolan: Actually, a more intensive experience and messaging to space i'm not sure if we have brandon I think we just see again the opportunity to bring them into the discussion again.

02:53:01.230 --> 02:53:09.840
Lorraine Nolan: i'm not hearing any pickup so I guess that we have keep moving, because I know the time is ticking by so we probably are coming towards the conclusion.

02:53:10.440 --> 02:53:17.070
Lorraine Nolan: I think we've had a fantastic discussion and I do very much so get the sense from all our panelists that the experience.

02:53:17.400 --> 02:53:22.770
Lorraine Nolan: Over the past number of months has been very valuable and I think there is lots of food for thought in terms of.

02:53:23.130 --> 02:53:31.680
Lorraine Nolan: How inspection as a process is going to continue to evolve and I think there have been lots of contributions from each of our panelists that really give.

02:53:32.490 --> 02:53:44.220
Lorraine Nolan: Consideration in terms of what our future should look like so i'm going to maybe fire across to the Panel for one quick grant, and this we have about 30 seconds to each of you just to say.

02:53:44.520 --> 02:53:53.940
Lorraine Nolan: If you had one wish for something to be brought forward from the previous eight months and what would you go for so maybe you rushed rajiv i'll go to you first of all.

02:53:56.370 --> 02:54:05.880
Rajiv Desai: I think, as I said, this this kind of inspection mode will continue the only change that has happened is bringing the technology of.

02:54:06.720 --> 02:54:11.460
Rajiv Desai: The transmission the platform of virtual transmission, which is do.

02:54:12.240 --> 02:54:21.270
Rajiv Desai: Not not many companies or not all of us have the expertise, but we have developed it, what we have done is as the moma they also said that we don't carry cameras.

02:54:21.600 --> 02:54:37.980
Rajiv Desai: Know on a regular basis as well, but we hired some of the local I would say studio so who can bring in this cameras and also support us and to see the compatibility of these cameras with our technology and also the.

02:54:39.090 --> 02:54:48.060
Rajiv Desai: The technology that we use, well, it says zoom model itself teams so anything that we use should be compatible and that's what we are protected on.

02:54:49.650 --> 02:54:50.610
Rajiv Desai: So I would say that.

02:54:51.810 --> 02:54:53.910
Rajiv Desai: This this will continue and.

02:54:54.960 --> 02:55:11.820
Rajiv Desai: I would say it is not really added to any additional resources in terms of the preparation or getting ready, but it's only the technology that has been added to which the it folks help us and we just make sure that we have enough of bandwidth on the Internet to.

02:55:11.850 --> 02:55:27.090
Rajiv Desai: support you to some of the sites are remote and we keep at least one or two backup in case something goes wrong and that's that's worked really well, so I would say that we have been very consistent in approaching the recent times.

02:55:27.750 --> 02:55:33.330
Lorraine Nolan: Thank you reggie so we'll go next to Paula your wish your one wish for the next 18 months.

02:55:34.260 --> 02:55:40.440
Paula Walker: My one wish so in 30 seconds for the next 18 months, I think, for me it would be early engagement.

02:55:40.830 --> 02:55:52.470
Paula Walker: I think it's something it's been spoken about a lot throughout the session, but I think it applies equally to inspections as well if we get early engagement on inspections, not only are they a regulator to.

02:55:52.710 --> 02:55:57.300
Paula Walker: That they can also very much be an enabling tool there's also picking up any issues.

02:55:57.570 --> 02:56:08.280
Paula Walker: early on that can be corrected early on, so we're not guessing to the stage where the marketing authorization application submission has been Putin, for example, and then we see the issues.

02:56:08.580 --> 02:56:18.480
Paula Walker: That being picked up early so early engagement early interaction with the regulators, noting the call from earlier discussions on harmonization of approaches, I think, for me.

02:56:18.810 --> 02:56:22.830
Paula Walker: That would be the thing to take forward, and I agree completely with with reggie that.

02:56:23.400 --> 02:56:40.470
Paula Walker: What we can expect to see continued innovation in those inspection approaches continual changes in usage of technologies but sitting alongside the more traditional inspection approaches, where the appropriate where they're replicable and where that's the best use of results.

02:56:41.790 --> 02:56:43.710
Lorraine Nolan: And Caroline same question to you.

02:56:44.760 --> 02:56:54.870
Caroline Bell: yeah, I think, as the others just acknowledge that you know we we do expect this format to continue, but I guess, for me it would be and could we look at expanding.

02:56:55.200 --> 02:57:07.530
Caroline Bell: The reliance procedures to include virtual inspections as well to help limit the resource impacts on both the regulator's on the industry and support this this this type of inspection.

02:57:08.370 --> 02:57:11.280
Lorraine Nolan: plastic so Derek same question to you.

02:57:13.110 --> 02:57:20.610
Derek Smith, US FDA: I think not, not much additional data, and I think as sort of we talked about the resource strain it that's what we've that we've seen I think it's.

02:57:20.880 --> 02:57:33.780
Derek Smith, US FDA: Continuing to refine our utilization of these alternative approaches to become more efficient and really and really become a tool that that stays in the toolbox, so that we can go from there chapstick.

02:57:33.840 --> 02:57:34.560
Lorraine Nolan: At Steve.

02:57:35.700 --> 02:57:44.040
Steve Mendivil: I would also echo what carolyn said about the the have better reliance on inspections between purgatory authorities, but also.

02:57:44.370 --> 02:57:54.960
Steve Mendivil: Maybe a joint regulator virtual on site hybrid approach for inspections, where you have a local inspectorate on site with other inspector it's participating.

02:57:55.350 --> 02:58:06.180
Steve Mendivil: Virtually and then maybe this joint virtual inspection could simulate the normal on site inspections, with less travel right, especially critical during a pandemic.

02:58:06.570 --> 02:58:20.820
Steve Mendivil: Yet having someone on site to tech check things like data integrity and other concerns that may be more difficult to assess virtually and I think that this joint hybrid approach could have create a lot of efficiencies for regulators and industry so.

02:58:21.060 --> 02:58:23.130
Lorraine Nolan: super high that approach Steve I think.

02:58:23.460 --> 02:58:24.180
Steve Mendivil: super do.

02:58:24.360 --> 02:58:26.040
Steve Mendivil: super hybrid okay.

02:58:26.550 --> 02:58:28.500
Lorraine Nolan: mama do we ask you the same question.

02:58:30.090 --> 02:58:39.780
Mohammed Alageel, SFDA: Yes, as what discussed from my colleagues, I believe, in addition to utilizing the very much destruction by using the technology, I believe.

02:58:40.560 --> 02:58:57.450
Mohammed Alageel, SFDA: it's a it's really important to increase the aggravation and enhance the lines between the different facilities to Boise through sharing the knowledge, information and experience and learn from each other's to do after getting back to all the.

02:58:59.940 --> 02:59:06.990
Lorraine Nolan: Thank you very much, and finally i'm going to give one more child I thought I heard brandon come over the intercom a moment ago brandon are you back in the room.

02:59:07.920 --> 02:59:08.940
Brendan Cuddy (European Medciines Agency): Yes, I was, I was.

02:59:11.730 --> 02:59:16.710
Brendan Cuddy (European Medciines Agency): I was screaming into the ether, and so sorry sorry about that I had terrible.

02:59:16.710 --> 02:59:17.010

02:59:18.120 --> 02:59:26.220
Brendan Cuddy (European Medciines Agency): laptop problems afternoon and it just affected my connection somehow, so thank you very much and apologies for the.

02:59:27.600 --> 02:59:33.450
Brendan Cuddy (European Medciines Agency): For the technical issues, so I yeah just maybe if I could say that.

02:59:33.480 --> 02:59:46.740
Brendan Cuddy (European Medciines Agency): Go ahead, I am the Chair of the emerging MP inspectors working group and the wg has been reflecting, of course, on the use of this assessment quite a lot.

02:59:48.000 --> 03:00:01.110
Brendan Cuddy (European Medciines Agency): Since they started a pandemic EU 27 Member States have carried out over 300 distant assessments now, at this stage so we're we're gaining a lot of experience with this assessment.

03:00:01.920 --> 03:00:24.090
Brendan Cuddy (European Medciines Agency): I have to say, though, that that's you know, only a fraction of what they would not normally do in terms of onsite inspections in any year, so you know, in terms of capacity or efficiency, maybe this is not going to add a great deal, two are done, indeed the wg and many other inspectorates.

03:00:25.200 --> 03:00:37.950
Brendan Cuddy (European Medciines Agency): consider that a distant assessment doesn't really replace an onsite inspection for for many different reasons, and that the primary method of GMP verification will remain the on site inspection.

03:00:39.570 --> 03:00:48.450
Brendan Cuddy (European Medciines Agency): And, and of course there are reasons for that, including you know from the risk assessment, the the intrinsic risk of the site may not lend itself to.

03:00:48.870 --> 03:00:56.730
Brendan Cuddy (European Medciines Agency): Do a distant assessment or the compliance risk may be too great to be managed through distance distant assessment.

03:00:57.720 --> 03:01:13.950
Brendan Cuddy (European Medciines Agency): There are feasibility issues, then that other speakers have alluded to, but these are you know, probably overcome with with time and as everyone gets used to the technology, whether it's cameras or it or whether it's communications.

03:01:15.180 --> 03:01:19.860
Brendan Cuddy (European Medciines Agency): But what we are seeing is that it is a lot more time consuming on site.

03:01:20.460 --> 03:01:29.910
Brendan Cuddy (European Medciines Agency): distant assessments take up maybe more time for the companies and I heard one of the industry speakers say that as well, and for inspectors as well.

03:01:30.660 --> 03:01:42.240
Brendan Cuddy (European Medciines Agency): It at the moment is is quite time consuming in terms of document review and sequencing that review with interviews of staff etc so.

03:01:42.600 --> 03:02:03.000
Brendan Cuddy (European Medciines Agency): So perhaps these are areas that could be worked on, as we move from the pandemic into more routine operations and then, of course, certain aspects are cannot be covered on site I listen to the the exchange on quality, culture and certainly you know some aspects of.

03:02:04.080 --> 03:02:15.060
Brendan Cuddy (European Medciines Agency): Personnel behavior maybe what you might see on site can be assessed with, even with the best iPad in the world, going around on a.

03:02:15.570 --> 03:02:22.200
Brendan Cuddy (European Medciines Agency): On a tray so, so there are some some weaknesses that we know about, of course, but I think.

03:02:23.010 --> 03:02:41.670
Brendan Cuddy (European Medciines Agency): Having said all that, and I don't want to sound very negative and I think there are and that's just a view of inspectors that i'm hearing, there are possibilities, I think, to use this and assessment in a hybrid way and, as we see within the EU 27 as we see.

03:02:43.530 --> 03:02:49.920
Brendan Cuddy (European Medciines Agency): Things opening up and onsite inspections are resuming on national territory we're seeing the use of hybrid.

03:02:50.250 --> 03:03:11.070
Brendan Cuddy (European Medciines Agency): Inspections with document reviews and limited on site inspections taking place at the moment, so certainly we'd see hybrid as as a tool that could be used in the future, but that pure da would probably remain reserved for emergency use maybe or in.

03:03:12.210 --> 03:03:17.430
Brendan Cuddy (European Medciines Agency): Some you know very extreme circumstances and maybe hybrid.

03:03:18.660 --> 03:03:26.520
Brendan Cuddy (European Medciines Agency): Applications could be used in the future and and certainly i'm thinking, particularly in relation to Q 12, for example, where.

03:03:26.790 --> 03:03:34.500
Brendan Cuddy (European Medciines Agency): You know, you might have hybrid inspections with inspectors on site looking at peak us assessments and and assessors looking at process and.

03:03:34.800 --> 03:03:44.580
Brendan Cuddy (European Medciines Agency): Product understanding, maybe remotely or some some combination of that type of approach, so I think that's that's really what i'd like to say.

03:03:45.300 --> 03:03:56.490
Brendan Cuddy (European Medciines Agency): I think there is a future for distance assessment within a within the toolbox, and you know it still remains to be seen how we can apply it going forward but.

03:03:57.510 --> 03:04:03.900
Brendan Cuddy (European Medciines Agency): yeah that's the view I think I hope of the inspectors, and I hope i've expressed that well, thank you.

03:04:04.470 --> 03:04:15.360
Lorraine Nolan: Madam chair brandon i'm delighted to get your contribution there at the end so look we've gone a little bit over, so I think we have to very quickly hand back to emerge as the moderator but just to say a huge thanks to all of the panelists.

03:04:16.020 --> 03:04:20.460
Lorraine Nolan: For sharing your insights with us today, and thank you for what was a high quality, discussion and.

03:04:21.930 --> 03:04:35.250
Emer Cooke: Thank you very much, Lorraine, and thanks to all the panelists and I see we actually have we had allocated five minutes to David and five minutes to me, David i'm going to give you two minutes.

03:04:36.750 --> 03:04:44.850
David Jefferys: And you i'll be very brief, indeed, I think the answer to this meeting, we said today, will be a milestone workshop I think that's what it's proved to be.

03:04:45.210 --> 03:04:57.150
David Jefferys: I think the case histories allowed industry to share a lot of information, a lot of virtual experiences I think Similarly, the regulator's I think we've had very rich discussions already.

03:04:57.720 --> 03:05:03.930
David Jefferys: In the kind of discussions and hopefully that will set you all up for your clothes meeting tomorrow as regulators.

03:05:04.380 --> 03:05:17.550
David Jefferys: I think, from the industry side, we very much welcome the cooperation, the collaboration and obviously co creation we should be a feature of this pandemic and I think that's been shown me today.

03:05:18.090 --> 03:05:27.390
David Jefferys: as well the suspect or we suspect that there may be a need for some further task forces workshops groups to come together if there are.

03:05:27.720 --> 03:05:37.560
David Jefferys: Concerned half industry we'd be very happy to join with you on that, as we take this agenda forward i've got certainly got a long list here i'm sure everybody has another meeting is being recorded.

03:05:37.800 --> 03:05:48.630
David Jefferys: I think we've touched on a lot of issues we had reliance cmc guys, a lot of emphasis around Q 12 and needing to go further around post authorization commitments.

03:05:49.050 --> 03:05:54.990
David Jefferys: I think I won't iterate on those I think that has been recorded, but I think we've had a rich discussion today.

03:05:55.350 --> 03:06:08.520
David Jefferys: So I think we also very much recognize that there will be some longer term issues which needs to be taken forward with I ch indeed perhaps for learnings the future pandemic preparedness but we're not out of this crisis yet.

03:06:08.880 --> 03:06:16.590
David Jefferys: So I think the only thing I would also like to say is on behalf industry a huge Thank you to be on both sides who made today possible.

03:06:16.890 --> 03:06:33.270
David Jefferys: Normally, such a meeting takes 912 months This is all being done around four to six weeks I think has been highly successful, so thank you very much, a lot of regional earnings and we stand by to work with you to take this forward, hopefully, that was about one minute 50 seconds.

03:06:34.020 --> 03:06:53.580
Emer Cooke: Absolutely David, thank you very much, Sir, so it's left to me now to just overly conclude this session, we are a bit over, but I think we've had such a rich discussion that it really didn't make sense to interrupt people on the way I would also like to share the thanks.

03:06:54.690 --> 03:07:05.790
Emer Cooke: With up to all the organizers to thank FDA for hosting the workshop to the organizing Group to the participants to the moderators and the panelists.

03:07:06.270 --> 03:07:15.480
Emer Cooke: And those are provided the content, content and expertise, the industry group led by janice burnout and the regulator's group led by three so Mullen.

03:07:15.870 --> 03:07:27.000
Emer Cooke: As David said this was a really a high quality, events that was prepared in a very short period of time we had over 330 participants.

03:07:27.660 --> 03:07:39.930
Emer Cooke: Online a lot of questions if you haven't looked look in the Q amp a a lot of questions have been answered tomorrow, we have a debt regulate free day with.

03:07:40.620 --> 03:08:03.420
Emer Cooke: Regulators from from extra I think we've we've almost 200 participants registered for our day tomorrow we reflect on the challenges that have been discussed during the workshop with with respect to reflect on this natural experiment missing the excitement of inspections, how we can.

03:08:04.830 --> 03:08:14.130
Emer Cooke: The importance of knowledge and dialogue and will also reflect on the best way to take some of the issues that have come up here forward.

03:08:14.610 --> 03:08:25.800
Emer Cooke: So we will we will come back to this is, this is not the end of the dialogue we will certainly have a lot of feedback over the next weeks and months.

03:08:26.370 --> 03:08:45.540
Emer Cooke: And we really thank everybody for tuning in and for all the insights we got on all of the issues that were discussed by both regulators and industry have a good unsafe rest of the afternoon evening our morning, thank you very much bye bye.