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

Learn the strategic and operational aspects of global risk management. The course will cover key concepts, principles, and tools necessary to develop risk management programs.

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Session 13: 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.

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

Session 13: EU-RMP Case Study

Session Chair(s)

Carla Barrett, PharmD

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