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Session 1: Fireside Chat with Dr. Robert Califf: Shaping the Future of Post-Market Safety, Global Harmonization, and More
Session Chair(s)
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Patient Safety Officer , Bristol Myers Squibb, United States
Join Dr. Robert Califf for a candid, conversational keynote featuring personal reflections and forward-looking perspectives for pharmacovigilance and post market evaluation of medical products. The discussion will highlight challenges in post-market evaluation in the U.S., the importance of global harmonization in risk management, and the promising role of real-world data and real-world evidence in enhancing post-market safety. The conversation will also explore the evolving role of REMS in drug and biologic safety and its place in future benefit-risk management.
Speaker(s)
Keynote Speaker
Instructor, Medicine, Duke University School of Medicine, United States
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