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 11: Post-Approval Requirements for EU-RMPs and REMS
Carla Barrett, PharmD
Senior Director, Patient Safety
PRA Health Sciences, United States
This session will guide learners through the implementation and monitoring of additional pharmacovigilance and additional risk minimization measures. The requirement to evaluate the impact or effectiveness of risk management activities, including process and outcome indicators, will be discussed.