REMS and RMPs
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.
At a Glance
- Target Audience: This course is beneficial for lifecycle safety, pharmacovigilance, regulatory and quality assurance professionals seeking foundational knowledge of risk management in the US, EU and Canada.
- Learning Level: Basic
- Total Length of Course: 3 Hours
- RAC Points: 3
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Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
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, EU and Canada
- Outline the major differences in risk management requirements and regulations between the US, EU and Canada
- Describe the federal framework for risk management activities in Canada
- 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).
Lesson Titles
- Lesson 1: Overview of Drug Risk Management
- Lesson 2: Risk Minimization Approaches
- Lesson 3: Timing Your Approach to Regulatory Agencies
- Lesson 4: Lifecycle Management and REMS & RMPs
- Lesson 5: The Potential Future of Patient Safety
This course is also included in:
