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Pharmacovigilance Big Data Sub-WG: Policy Paper and Inventory

February 13, 2018

The ICMRA Pharmacovigilance working group was formed to examine gaps in current pharmacovigilance practices. The ICMRA Pharmacovigilance Big Data sub-group was tasked in 2016 to examine the opportunities and challenges for big data and analytics within the context of pharmacovigilance and to facilitate international collaboration in this area, where feasible. The Sub-group has grown to 13 members and through a series of meetings has developed a policy paper and an inventory of big data initiatives in pharmacovigilance, which are attached here. Both documents have been endorsed by ICMRA.

The policy paper and inventory represent a snapshot in time (information collected prior to September 2016) that informed the discussions of the subgroup, and may not adequately more recent capture developments since they were originally compiled.