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Virtual Training Course (US Eastern Time)

Jun 22, 2020 3:00 PM - Jun 25, 2020 5:30 PM

Benefit-Risk Assessment and Management Across the Lifecycle

Attend this virtual training course to learn about benefit-risk assessment methods and how to incorporate the patient perspective.

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Session 2: Benefit-Risk Overview

Session Chair(s)

Mary Mease, MPH, RPh

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.

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