CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive - June 15th 2017 - 12:00pm - 3:00pm (Eastern)
This event is FREE
The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our webinar series.
These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
CDER invites you to view our webinar: Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive which was held on June 15, 2017.
This extended webinar format, with Q&A sessions, was 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 Risk Evaluation and Mitigation Strategies (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 described the history of the REMS SPL project, provided an introduction to SPL, and described the role of REMS SPL in standardizing REMS and integrating them into the healthcare delivery system.
Speakers:
Elaine Lippmann, J.D.
Senior Regulatory Counsel
Office of Regulatory Policy
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Adam Kroetsch, MSPPM
Deputy Director (Acting)
Office of Program and Strategic Analysis
CDER | FDA
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
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Risk Evaluation and Mitigation Strategies - Purpose, Process, and Challenges
- Risk Evaluation and Mitigation Strategies - Purpose, Process, and Challenges
- Webinar (mp4)
- Audio (mp3)
Resources
Risk Evaluation and Mitigation Strategies in Structured Product Labeling Format: An Introduction
- Risk Evaluation and Mitigation Strategies in Structured Product Labeling Format: An Introduction
- Webinar (mp4)
- Audio (mp3)
Resources
- REMS@FDA
- REMS Integration Initiative
- Structured Product Labeling Resources Website
- Submitting REMS in SPL Format (Webinar 08-24-16)
- DailyMed (Future home of REMS SPL Data Files)