DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation
Venue: Marriott Key Bridge
|Event Date/Time: Oct 14, 2008||End Date/Time: Oct 15, 2008|
â€¢Challenges and Opportunities to Improve Pre-marketing Safety Planning, Evaluation, and Reporting
â€¢Combining Safety Data at a Development Program Levelâ€”Data Collection and Study Design
â€¢How to Improve Safety Data Analysis and Reporting
â€¢Safety Boundaries for Data Monitoring Committees (DMCs)
â€¢Planning for Effective Meta-analysis: What Constitutes Good Meta-analysis and What are the Limitations?
â€¢Regulatory Decision Making Based on Meta-analysis Results
â€¢Meta-analysis for Rare Events from Clinical Trials
â€¢Meta-analysis for Observational Data.