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Session 11: 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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