Safety Risk Management: A Focus on EU RMPs and US REMS

Learn the strategic and operational aspects of global risk management. The course will cover key concepts, principles, and tools necessary to develop risk management programs.

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Session 6: Content of a US Risk Evaluation & Mitigation Strategy (REMS)

Session Chair(s)

Carla Barrett, PharmD

Vice President, Global Risk Management

Novavax, United States

This session will review the requirements for a REMS in the US, including discussions on shared system REMS. The FDA REMS website will be demonstrated.

Safety Risk Management: A Focus on EU RMPs and US REMS

Session 6: Content of a US Risk Evaluation & Mitigation Strategy (REMS)

Session Chair(s)

Carla Barrett, PharmD

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