10th ICMRA Teleconference Minutes COVID-19 Real-World Evidence observational studies Working Group

Monday 26 February 2024

Chairs: Kelly Robinson (Health Canada - HC) and Peter Arlett (European Medicines Agency - EMA)

1. Welcome and introduction

Kelly Robinson and Peter Arlett opened this 10th, and closing, ICMRA meeting on COVID-19 Real-World Evidence and Observational studies with a warm welcome to all the participants. The aim of the teleconference was to discuss the lessons learned manuscript and mandate for the new ICMRA WG on RWE.
 

2. Discussion on the draft manuscript on lessons learned

The lessons learned manuscript was previously shared with members for feedback and comments. Health Canada provided an overview of the project timeline and lessons learned manuscript. 

Key lessons learned from the ICMRA Working Group (WG) experience highlighted:

  • Uncertainty in the evidence and collaborations to address knowledge gaps;
  • Rapid response and the necessity for a governance structure;
  • Collaborative project management;
  • Importance of information sharing among regulators and a broader audience;
  • Various challenges.
     

Recommendations based on the lessons learned included:

  • Develop an international governance structure;
  • Coalition of the willing;
  • Create dedicated sub-groups;
  • Periodic workshops;
  • Develop common protocol, timelines, and data model templates;
  • Leverage existing infrastructure;
  • Strengthen outreach for transparency and engagement.
     

Future developments for the new WG underscored:

  • Establishment of governance principles;
  • Optimized resource use;
  • Collaborative preparedness studies;
  • Communication and transparency;
  • Continual evaluation for efficiency.
     

During discussions, participants shared their experiences in overcoming challenges and emphasized the necessity of maintaining an "ever-warm" status to minimize time loss during future public health emergencies. The meeting concluded with an acknowledgment that the lessons learned report would serve as the problem statement and mandate for the new WG. Additionally, there was a query regarding the determination of the "ever-warm" status, with plans to address this in subsequent discussions and meetings of the new WG. Potential study topics to sustain the group's readiness include e.g. background rates for adverse events of special interest for vaccines, as well as proof of concept studies and methods development focusing on repurposing medicines within the realm of observational studies.
 

3. Draft mandate of new ICMRA WG on RWE with a focus on public health emergencies

The mandate for the new WG was previously shared with members for feedback and comments. The EMA presented on the draft mandate and provided a reminder to members on the role of ICMRA, outlining its high-level governance structure and working groups. The lessons learned survey prompted the repurposing of the WG to focus on RWE generation for public health emergencies preparedness. 

The mandate and objectives of this new WG were presented: 

  • A forum to facilitate international collaborations between interested regulatory agencies to enable RWE for regulatory decision-making;
  • Proactively enhance the efficiency of critical responses in case of new public health emergencies (PHE) through collaborative studies;
  • Optimise preparedness by leveraging existing infrastructures to test the measures in place and to keep the WG ‘ever-warm’;
  • Potential to expand to other topics (e.g. pregnancy studies, rare diseases);
  • Close interactions with other ICMRA WG, and other relevant structures;
  • Information and knowledge sharing;
  • Transparency;
  • Processes to continuously improve efficiency in line with its strategic objectives.
     

Membership details were outlined, with the WG to be co-chaired by EMA and HC, offering core and associate memberships for regulatory agencies. Regulatory agencies may request to join the WG as a core or associate member at any time by contacting the EMA and HC secretariats. The operational aspects, including agile governance principles and processes, and workplans for 2024 and 2025, were presented.

  • 2024: adoption of mandate, landscape analysis of RWE initiatives ongoing and planned, kick-off discussions on governance principles and processes, draft list of topics for future collaborative projects.
  • 2025: launch first collaborative study, may expand collaborative work to other topic areas.
     

During the discussion, topics such as membership commitments and the landscape analysis of RWE research agendas were raised. A pragmatic approach to the landscape analysis will be important, with the objective to particularly identify which agencies have the capacity and could be involved in a future collaborative study, and to understand the agencies’ priorities in order to set the baseline for future collaborative work on RWE.

Additionally, the African Union's Smart Safety Surveillance (AU-3S) initiative was mentioned, showcasing the potential for broader international engagement.
 

4. Summary and next steps

It was agreed that HC and EMA would re-circulate the mandate and lessons learned report for member feedback by 15 March 2024. The documents will then be updated by EMA and HC based on any comments received. 

The updated manuscript will be submitted by HC to a scientific journal for publication. 

The updated mandate will be sent to ICMRA Executive Committee (EC) for adoption at its April 2024 meeting. A call for expressions of interest to be part of the new ICMRA WG is expected to be launched in April, upon adoption of the mandate by ICMRA EC. The first WG meeting is scheduled to be held in June or July 2024, marking the commencement of collaborative efforts towards the outlined objectives.

 

Invited participants:

  1. Therapeutic Goods Administration (TGA), Australia;
  2. National Administration of Medicines, Food and Medical Technology (ANMAT) Argentina;
  3. National Health Surveillance Agency (ANVISA), Brazil;
  4. Health Products and Food Branch, Health Canada (HPFB-HC), Canada;
  5. National Medical Products Administration (NMPA), China; 
  6. Center for the State Control of Medicines, Equipment and Medical Devices (CECMED) Cuba;
  7. European Medicines Agency (EMA), European Union;
  8. European Commission - Directorate General for Health and Food Safety (DG - SANTE), European Union; 
  9. National Agency for Medicines and Health Products Safety (ANSM), France; 
  10. Paul-Ehrlich-Institute (PEI), Germany; 
  11. Health Product Regulatory Authority (HPRA), Ireland; 
  12. Italian Medicines Agency (AIFA), Italy;
  13. Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan; 
  14. Ministry of Food and Drug Safety (MFDS), Korea; 
  15. Federal Commission for the Protection against Sanitary Risks (COFEPRIS), Mexico; 
  16. Medicines Evaluation Board (MEB), Netherlands; 
  17. Medsafe, Clinical Leadership, Protection & Regulation, Ministry of Health, New Zealand; 
  18. National Agency for Food Drug Administration and Control (NAFDAC), Nigeria; 
  19. Health Sciences Authority (HSA), Singapore; 
  20. South African Health products Regulatory Agency (SAHPRA), South Africa; 
  21. Medical Products Agency, Sweden; 
  22. Swissmedic, Switzerland; 
  23. Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom; 
  24. Food and Drug Administration (FDA), United States;
  25. World Health Organization (WHO);
  26. Austrian Agency for Health and Food Safety Ltd. (AGES), Austria;
  27. Danish Medicines Agency, Denmark;
  28. Office of Medical Technology, Health Information and Research (MTHIR), Israel;
  29. Office of Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB), Poland;
  30. Spanish Agency of Medicines and Medical Devices (AEMPS), Spain.