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Sheraton Philadelphia University City

2019年10月17日 (木) 午前 8:00 - 2019年10月18日 (金) 午後 3:00

3549 Chestnut Street, Philadelphia, PA 19104

Benefit-Risk Assessment and Management Across the Lifecycle

Learn about the principles, legal, and regulatory basis for benefit-risk obligations and frameworks for compliance.

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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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