Larry A. Risen, President of BioTrak Research will be speaking at the 3rd Risk Evaluation and Mitigation Strategies Summit January 24-25, 2011 in Arlington, VA.
- Review of recent developments impacting current requirements for REMS assessments
- Results from assessments covering the first approved REMS programs
- New FDA attempts at standardizing REMS assessment question content and format - Executing a successful REMS assessment using best practices in protocol design, sampling methodology, and reporting measurements
- Understanding what the FDA wants
- Applying root cause analysis for determining corrective actions
- Leanings from the first wave of REMS assessment reports and it’s influence on the future of REMS assessments
More information on the 3rd REMS Summit to follow