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May 9, 2012

From Compliance to Care: Moving the Needle on Standard REMS Communication Metrics

Since passage of the Food and Drug Administration Amendments Act (FDAAA) there have been 55 Risk Evaluation and Mitigation Strategy (REMS) requirements, as of March 8, 2012, that have included communication plans but metrics on these communications have typically focused on logistics, such as the number of targeted prescribers or open rates.  None have used Continuing Medical Education (CME) as a vehicle to (1) transfer such communication into an educational format or (2) use such a format to capture non-logistical data that would have clinical as well as regulatory impact.

In this edition of our Wednesday FoREMS webinar, we will illustrate how CME cannot only support a REMS communication requirement, but augment such a requirement with more granular data that can inform stakeholders on the impact of these communications.

  • Demonstrate how CME can support a REMS communication requirement
  • Discuss how CME can augment a REMS requirement
  • Understand the impact of these communications
  • Jeff Fetterman – President, ParagonRx
  • Carl Kraus – Vice President of Medical Affairs, Medscape & WebMD


Webinar Slide Set:




Session Replay:

To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email