March 13, 2013
Wednesday FoREMS: Digging into the OIG Report on REMS Assessments
In February 2013, The Office of the Inspector General (OIG) issued a report, FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety, which raises concerns with the way the performance of REMS are assessed as well as the overall effectiveness of REMS programs. REMS assessments are a significant part of the ongoing cost and effort to comply with REMS requirements. It is essential for risk management professionals and other individuals associated with REMS assessments to be fully informed of the findings of the OIG report. This webinar provides an evaluation of the methodologies, findings, and recommendations of the report.
Key questions that will be addressed:
- Who is the OIG and why is this investigation important?
- What were the methodologies, findings, and recommendations?
- What are the key insights that are important for risk management professionals?
- What actions do we recommend for drug sponsors of products with REMS?
- Jeff Fetterman – President, ParagonRx
Reports addressed during webinar:
- OIG Report
- Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making (mentioned at the conclusion of the webinar)
Webinar Slide Set:
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