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Virtual Training Course (US Eastern Time)

Sep 14, 2020 9:00 AM - Sep 17, 2020 1:00 PM

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

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

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Session 13: REMS Case Study

Session Chair(s)

Carla Barrett, PharmD

Carla Barrett, PharmD

Vice President, Global Risk Management

Novavax, United States

    The REMS group will be asked to provide an overview of the fictional REMS, describe the product’s risks, discuss the objectives of the REMS, review the additional risk minimization activities selected, and present the plan for implementation and evaluation as if they were presenting to an internal Safety Management Team and/or the Food and Drug Administration (FDA) for approval.

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