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 10: Development of the Risk Management Strategy and Authoring Risk Management Documents
Carla Barrett, PharmD
Senior Director, Patient Safety
PRA Health Sciences, United States
This session will provide details on how to develop the risk management strategy by defining a product’s risks to patients, developing a plan for pharmacovigilance, developing a plan for risk minimization, determining how to implement the actions, and addressing regional variations of risk management strategies. This session will also describe the process for authoring Risk Management Documents such as EU-REMPs and REMS, as well as related safety documents.