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Session 7: Post-Authorisation Safety Studies and Registries
Session Chair(s)
Bianca Mulder, PHARMD, MPHARM, MSC
Pharmacovigilance Assessor, Medicines Evaluation Board, Netherlands
Post authorisation safety studies and registries can provide valuable information on the safety of a medicinal product. The information from these studies and registries is used to evaluate the safety and benefit-risk profile of a medicine and support regulatory decision-making. This session will be dedicated to current developments and challenges with regard to these studies and registries. There will be perspectives from Industry, the EMA and the NL regulatory agency.
Speaker(s)
Bianca Mulder, PHARMD, MPHARM, MSC
Pharmacovigilance Assessor, Medicines Evaluation Board, Netherlands
Post Authorisation Studies and Implementation of Results
Ulka Campbell
Senior Director, Epidemiology, Pfizer, United States
The Impact of Non-Europeans PAS on PV systems in Europe and Globally
Valerie Strassmann, PHD, RPH
Scientific Administrator, Data Analytics and Methods Task Force, European Medicines Agency (EMA), Netherlands
The Potential of Patient Disease Registries