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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:45 PM - Apr 10, 2019 9:45 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Drug Safety and Pharmacovigilance Across the Product Lifecycle

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Session 25: Benefit-Risk Management

Session Chair(s)

Mark Vieder, MBA, RPh

Vice President, Drug Safety and Pharmacovigilance

Biorasi, LLC, United States

The session will provide an introduction to benefit-risk assessment, with a focus on formal post-marketing risk management, primarily in the US and EU context. This session will encompass post-marketing risk assessment, Risk Management Plans (RMPs), and Risk Evaluation and Mitigation Strategies (REMS).