Wednesday FoREMS
Wednesday FoREMS: "Hot" Topics in REMS Assessments
October 13, 2010Of 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:
Presenters:
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
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