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 strict risk management tools were implemented in 1989 to maintain product availability and provide beneficial drugs to patients while minimizing risks to patients. 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 and Risk Management Plans (RMPs) in the EU.
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 for the US and EU. It discusses methods for conducting successful risk management programs and developing an organization to support lifecycle safety and explores the future of risk management.
Learning Objectives
Upon completion of this course, participants should be able to:
- Describe the philosophy of risk management
- Explain the factors that should be considered in planning a risk management strategy
- Identify the primary regulations and guidance governing risk management practices in the US and EU
- Outline the major differences in risk management requirements and regulations between the US and EU
- Describe the characteristics of the “culture of safety”
- Describe the components of REMS and provide examples of when one would choose a medication guide, communication plan and elements to assure safe use (ETASU).
Target Audience
This course is beneficial for lifecycle safety, pharmacovigilance, regulatory and quality assurance professionals seeking foundational knowledge of risk management in the US and EU.