This short course,will cover lessons learned over the last decade of REMS implementation, and how implementation approaches continue to evolve to support safe use and product access, while reducing overall burden of REMS on the healthcare landscape. Using examples from approved REMS programs, we explore how key concepts are applied in the real world. By the end of this short course, participants have an expanded understanding of REMS and the knowledge necessary to be involved in development, approval, implementation, and/or administration of a REMS program.
At the conclusion of this short course, participants should be able to:
- Describe business and regulatory challenges unique to products with an associated REMS
- Summarize how REMS programs are initiated, developed, approved, launched, and operated
- Discuss the differences and similarities between new product and generic product REMS programs.