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October 13, 2010

Wednesday FoREMS: "Hot" Topics in REMS Assessments Of the 146 FDA REMS programs approved to date, 41 of them - almost one-third - have already been modified. Undoubtedly, REMS assessment findings have played a role. In addition, new insights arising from FDA comments influence the design of future assessm

Of the 146 FDA REMS programs approved to date, 41 of them - almost one-third - have already been modified. Undoubtedly, REMS assessment findings have played a role. In addition, new insights arising from FDA comments influence the design of future assessments. This month's Wednesday FoREMS webinar will address many of these topics:

Outline:

  • Recent unofficial guidance: Insights from FDA responses to Sponsors
  • Appropriate sample size for surveys
  • The regulatory compliance basis of REMS assessments
  • Influence of Medication Guide changes on a REMS assessment
  • Performance benchmarks and expected results from assessments
  • Corrective actions based upon assessment results
  • Q&A: Ask the Experts

Presenters:

  • Karen Lenoir, Client Services Director, ParagonRx
  • Larry Risen, President, BioTrak Research

 

To register, follow this link - Wednesday FoREMS Registration


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