Over the past decade, risk management has gained increased global visibility due to several high-profile drug safety issues; however, risk management tools have been used since the beginning of modern drug development. More-stringent risk management tools—boxed warnings, market withdrawal, patient screening and limited distribution—have been implemented since 1989 to maintain product availability and provide beneficial drugs to patients while minimizing risks. Risk management and the associated guidance and regulations have continued to evolve. The most recent significant risk management programs are Risk Evaluation and Mitigation Strategies (REMS) in the US, Risk Management Plans (RMPs) in the EU and the developing framework for risk management activities in Canada. FDA was given the authority to require REMS, which have had a major influence on postmarketing safety in the US, under the Food and Drug Administration Amendments Act of 2007 (FDAAA).
This course provides an overview of the history of risk management, reviews risk management philosophies and examines regulatory requirements and interactions between industry and regulators in the US, EU and Canada. It discusses methods for conducting successful risk management programs and developing an organization to support lifecycle safety and explores the future of risk management.