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The State of Real-World Evidence for Regulatory Decision-Making: Views from FDA, EMA, and PMDA
Session Chair(s)
Charles Lee, MBA, MS
Executive Regulatory Science Director
AstraZeneca, United States
This session will be a panel discussion with senior leaders from FDA, EMA, and PMDA who are closely involved with real-world evidence (RWE) initiatives within their respective agencies. An open Q&A with leaders in RWE from FDA, EMA, PMDA, will be included.
Learning Objective : Describe current perspectives of regulators from several agencies on the use of real-world evidence (RWE) for regulatory decision-making; Discuss from examples of successful use of RWE in regulatory decision-making and how they can be applied; Identify current initiatives and programs regarding RWE in each regulatory agency.
Speaker(s)
FDA Update
Motiur Rahman, PhD, MPharm, MS
FDA, United States
Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER
EMA Update
Sabine Haubenreisser, PhD, MSc
European Medicines Agency, Netherlands
Principal Scientific Administrator, Stakeholders and Communication Division
PMDA Update
Yuki Ando, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Senior Scientist for Biostatistics
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