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Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time
Session Chair(s)
Saad Shakir, MD, FFPM, FISPE, FRCP
Pharmacovigilance Physician and Pharmacoepidemiologist, ADROITVIGILANCE, United Kingdom
This session will discuss the recent shifts in evidence-based regulatory decision-making, to include types of evidence used to support decisions. Future requirements for evidence generation to support regulatory decision-making will be considered.
Learning Objective : Describe the need for evidence generation to support regulatory decision-making; Discuss the changing evidence landscape supporting regulatory decision-making; Identify what is needed in the future.
Speaker(s)
Saad Shakir, MD, FFPM, FISPE, FRCP
Pharmacovigilance Physician and Pharmacoepidemiologist, ADROITVIGILANCE, United Kingdom
The Changing Trends in the Evidence Supporting Major Regulatory Decisions (Products Withdrawals) in Europe
Samantha Lane, MSC
Head of Research, Centre of Pharmacovigilance Sciences, Drug Safety Research Unit, United Kingdom
Quantitative Measurement of the Public Health Impact of Medicines Withdrawals and Suspensions in Europe
Andrew Bate, PHD, MA
Vice President, Head of Safety Innovation and Analytics, GSK, United Kingdom
Industry Update
Jeremy Jokinen, MS
Vice President Global Patient Safety, Argenx, United States
The changing trends in the evidence supporting major regulatory decisions: Industry perspective
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