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September 10, 2014

FoREMS & More: REMS Assessments Seven Years After FDAAA

12 pm New York time, 9 am California time, 5 pm London time

The FDA Amendments Act of 2007 created Risk Evaluation and Mitigation Strategies (REMS) and the need to periodically assess the performance of those programs.  Working with sponsors, FDA is striving to standardize and improve the process for REMS performance evaluation and reporting, but there continues to be ongoing uncertainty about standards.  Seven years of experience have yielded much needed best practices and case examples that offer insight about how to navigate the REMS assessment process in order to meet regulatory expectations.  This webinar will provide a historical look at the evolution of REMS assessments, will feature a review of five specific case scenarios, and will offer recommendations of how to successfully manage REMS assessment requirements.  

Highlights:

  • Review of the regulatory basis for REMS assessments
  • Update on the evolution of REMS assessments and review five case scenarios
  • Provide best practices as they apply to the current state of REMS assessments
Speaker:
  • Karen Lenoir - Senior Director, Client Services, ParagonRx

To view the slides from this webinar, click here.

To view the recording for this webinar, click here.


To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email info@paragonrx.com