This three-day program will give attendees the opportunity to interact with speakers, global regulatory agency personnel and other participants in a dynamic and informative environment. Sessions will feature presentations, panel discussions, and Q&A.
- PDUFA V Overview
- Statisticians as Leaders
- FDA Upcoming Guidance Update (Multiplicity and Enriched Populations)
- Dichotomizing Continuous Measures for a Primary Efficacy Endpoint – Weighing the Benefits and Risks
- Measures for Primary Efficacy Endpoint – Are we Substantially Compromising Statistical Power?
- Pre-Competitive Collaboration
- Meta Analysis for Safety Data
- Companion Diagnostics
- (Pre-Marketing) Benefit-Risk Assessment in Clinical Development and Regulatory Review
- (Pre-Marketing) Benefit-Risk Assessments
- Health Technology Assessment and Comparative Effectiveness Research: Their Impact on Access to Pharmaceutical Products and Their Role in Designing Product Development Strategies
- Missing Data: When is it Important to Collect Data After Study Drug Discontinuation?
- Missing Data: Case Study Presentation and Panel Discussion
- Overview and Commentary of FDA Guidances: Multiplicity and/or Enriched Populations
- Statistical Methods for Safety Surveillance
- Benefit-Risk Evaluation
- Missing Data in Clinical Trials
Who Should Attend
- Drug safety professionals
- Regulatory and medical communication scientists