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.
Session 25: Benefit-Risk Management
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).