CDER SBIA invites you to our LIVE webinar: Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive on Thursday June 15th from 12:00pm – 3:00pm (Eastern).
This extended webinar format, with Q&A sessions, is intended to provide a deeper look at REMS, focusing on two topics:
- Risk Evaluation and Mitigation Strategies - Purpose, Process, and Challenges: An overview of FDA-required REMS for certain high-risk drugs - the purpose they serve in ensuring the benefits of certain drugs outweigh their risks, the process of developing REMS programs, and the unique challenges of the requirement for a single, shared system for generics and brand products.
- Risk Evaluation and Mitigation Strategies in Structured Product Labeling Format: An Introduction: An introduction to the use of structured product labeling as a format for REMS information. FDA will describe the history of the REMS SPL project, provide an introduction to SPL, and describe the role of REMS SPL in standardizing REMS and integrating them into the healthcare delivery system.
This webinar has been pre-approved by RAPS as eligible for up to 3 credits towards a participant’s RAC recertification upon full completion.
Please note that the credit is only available for participation in the live event and not for watching the recording afterwards.
For questions concerning the webinar, please contact CDER SBIA at: (866) 405-5367 | (301) 796-6707