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 13: EU-RMP Case Study
Carla P Barrett, PharmD
Senior Director, Patient Safety Risk Mgmt
PRA Health Sciences, 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.