Drug Safety and Pharmacovigilance Across the Product Lifecycle

Build a solid foundation in the key concepts of drug safety and pharmacovigilance throughout the medical product development lifecycle. Learn how to comply with regulatory requirements.

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Session 25: 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 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).