Presentations & Interviews
June 12, 2013
FoREMS & More Webinar: Advanced Concepts in REMS and Risk Minimization Assessment: A Review of the TERM Summit
June 12, 2013
Advanced Concepts in REMS and Risk Minimization Assessment: A Review of the TERM Summit
Conducting and documenting REMS assessments remains a significant challenge for all stakeholders associated with REMS. The following examples of recent events and publications demonstrate this:
- FDA has been charged by PDUFA V goals to issue guidance on methodologies for assessing REMS
- OIG issued a report earlier this year entitled, “FDA Lacks Comprehensive Data to Determine Whether REMS Improve Drug Safety”
- During a Social Science Survey and Methodology workshop in June 2012, pharmaceutical manufacturers cited the ongoing challenges with conducting and reporting REMS assessment surveys
Participants in this webinar will learn:
- High level review of meeting content
- Important new methods that may be useful in future REMS assessments
- Access to resources for further exploration of these topics or participation in research
- Michael Cheung, MS – Project Manager, Medical Affairs Risk Management, VIVUS
- Matthew Lee, PharmD – Associate Director, Risk Management, Lundbeck LLC
- Jeff Fetterman – President, ParagonRx
To view the slides from this webinar, click here.
To view the webinar playback, click here.
To view the Summit presentation slides that were referred to during this webinar, click here.
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