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

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Session 12: EU-RMP Case Study

Session Chair(s)

Carla Barrett, PharmD

Vice President, Global Risk Management

Novavax, United States

The EU-RMP group will be asked to provide an overview of the fictional EU-RMP, describe the product’s risks, discuss the additional PV and/or additional RMM activities selected, and present the plan for implementation and evaluation as if they were presenting to an internal Safety Management Team and/or the European Medicines Agency (EMA) for approval.

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

Session 12: EU-RMP Case Study

Session Chair(s)

Carla Barrett, PharmD

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