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 8: Content of an EU Risk Management Plan (EU-RMP)
Carla Barrett, PharmD
- Senior Director, Patient Safety
- PRA Health Sciences, United States
This session will review the requirements for an EU-RMP based on GVP Module V Risk Management Systems and GVP Module XVI Risk Minimization Measures: Selection of Tools and Effectiveness Indicators.