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

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Session 3: 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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Safety Risk Management: A Focus on EU RMPs and US REMS

Session 3: Global Risk Management Guidelines and Regulations

Session Chair(s)

Carla Barrett, PharmD

Be informed and stay engaged.