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Session 2: Benefit-Risk Overview
Session Chair(s)
Mary Mease, MPH, RPh
PV and Risk Management Strategy and Operations
Consultant, United States
- This session will provide an overview of the benefit-risk landscape with a focus on the US and EU. Case studies will be discussed that served as turning points in the benefit-risk arena. Topics to be covered include key terminology and definitions, the purpose of benefit-risk regulatory requirements, and timing of when benefit-risk assessments are usually performed.