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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.

Session 6: Content of a US Risk Evaluation & Mitigation Strategy (REMS)

Session Chair(s)

Carla P Barrett, PharmD

Carla P Barrett, PharmD

  • Senior Director, Patient Safety Risk Mgmt
  • PRA Health Sciences, United States
    This session will review the requirements for a REMS in the US, including discussions on shared system REMS. The FDA REMS website will be demonstrated.

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