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

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Session 10: Post-Approval Requirements for EU-RMPs and REMS

Session Chair(s)

Carla Barrett, PharmD

Vice President, Global Risk Management

Novavax, United States

This session will guide learners through the implementation and monitoring of additional pharmacovigilance and additional risk minimization measures. The requirement to evaluate the impact or effectiveness of risk management activities, including process and outcome indicators, will be discussed.

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

Session 10: Post-Approval Requirements for EU-RMPs and REMS

Session Chair(s)

Carla Barrett, PharmD

Be informed and stay engaged.