Wednesday FoREMS: Standardization of REMS in the Customized Healthcare Marketplace
Wednesday, February 8, 2012
Standardization of REMS in the Customized Healthcare Marketplace
Standardization is a central element of many recent presentations by FDA on future directions for Risk Evaluation and Mitigation Strategies (REMS). The opportunities for greater standardization of criteria, methods, and/or tools are many, including:
- Criteria for deciding whether a REMS is needed as well as what elements of a REMS are necessary
- Content and formatting of certain REMS materials
- Prescriber educational methods
This webinar provides essential insights for individuals responsible for the design, regulatory documentation, and/or operation of risk mitigation and REMS programs regarding existing and anticipated standards.
Highlights:
- Review recent communications and presentations by FDA related to REMS standardization
- Review existing standards and identify areas where greater standardization may evolve in the future
- Evaluate recent examples illustrating the emerging use of more standardized approaches in the FDA review of and/or direction for Proposed REMS programs
Speaker:
- Jeff Fetterman – President, ParagonRx
Webinar Slide Set:
Session Replay:
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