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 4: Global Risk Management Guidelines and Regulations

Session Chair(s)

Carla Barrett, PHARMD

Vice President, Global Risk Management

Novavax, United States

This session will review the guidelines for REMS and regulations for EU-RMPs, including associated documents and templates. Requirements for RMPs in other regions will be discussed.

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