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

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Session 6: Content of an EU Risk Management Plan (EU-RMP)

Session Chair(s)

Carla Barrett, PharmD

Vice President, Global Risk Management

Novavax, United States

This session will review the requirements for an EU-RMP based on GVP Module V Risk Management Systems and GVP Module XVI Risk Minimization Measures: Selection of Tools and Effectiveness Indicators.

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

Session 6: Content of an EU Risk Management Plan (EU-RMP)

Session Chair(s)

Carla Barrett, PharmD

Be informed and stay engaged.