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 14: REMS Case Study
Carla P Barrett, PharmD
Senior Director, Patient Safety Risk Mgmt
PRA Health Sciences, 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.