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Sheraton Philadelphia University City

Oct 23, 2017 3:45 AM - Oct 25, 2017 3:45 PM

3549 Chestnut Street, Philadelphia, PA 19104

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

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Session 27: Benefit-Risk Management

Session Chair(s)

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

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