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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
In an effort to begin addressing these challenges, the TERM Summit convened a panel of cross-disciplinary experts and an audience of risk management professionals to review promising research, methods, and technology to advance the assessment of risk minimization activities.  Speakers represented key stakeholders including regulatory, academia, NIH, pharma industry, and service providers.  This webinar provides highlights of these presentations.  

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

Speakers:

  • 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.


Have questions or want to schedule a presentation on-site?
call 888.459.8080 or email info@paragonrx.com