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

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Session 5: 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.

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

Session 5: Content of a US Risk Evaluation & Mitigation Strategy (REMS)

Session Chair(s)

Carla Barrett, PharmD

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