Course overview
On this course, participants will gain an in-depth understanding of the purposes, regulatory requirements, and practical implementations of both Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP) and their importance on drug safety. The course will highlight key differences and similarities and provide real-world examples to illustrate how each document is applied to the same product.
CPD Hours: 3
Course Content
- Day 1
- Introduction to REMS and RMP
- Regulatory framework
- Components of REMS and RMP
- Developing REMS and RMP
- Implementation and management
- Case study: comparative analysis
