Back to Agenda
Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time
Session Chair(s)
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP
Director
Drug Safety Research Unit, 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)
The Changing Trends in the Evidence Supporting Major Regulatory Decisions (Products Withdrawals) in Europe
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP
Drug Safety Research Unit, United Kingdom
Director
Quantitative Measurement of the Public Health Impact of Medicines Withdrawals and Suspensions in Europe
Samantha Lane, MSc
Drug Safety Research Unit, United Kingdom
Head of Research, Centre of Pharmacovigilance Sciences
Industry Update
Andrew Bate, PhD, MA
GlaxoSmithKline, United Kingdom
Vice President, Head of Safety Innovation and Analytics
The changing trends in the evidence supporting major regulatory decisions: Industry perspective
Jeremy Jokinen, PhD, MS
Bristol-Myers Squibb Company, United States
Vice President and Head, Safety Evidence and Sciences
Have an account?