This conference will stimulate discussion between FDA and industry participants for proactive planning of safety evaluation. This will include planning for data collection, integration, analysis (including meta-analysis) and reporting.
FEATURED TOPICS
鈥hallenges and Opportunities to Improve Pre-marketing Safety Planning, Evaluation, and Reporting
鈥ombining Safety Data at a Development Program Level鈥擠ata Collection and Study Design
鈥ow to Improve Safety Data Analysis and Reporting
鈥afety Boundaries for Data Monitoring Committees (DMCs)
鈥lanning for Effective Meta-analysis: What Constitutes Good Meta-analysis and What are the Limitations?
鈥egulatory Decision Making Based on Meta-analysis Results
鈥eta-analysis for Rare Events from Clinical Trials
鈥eta-analysis for Observational Data.
FEATURED TOPICS
鈥hallenges and Opportunities to Improve Pre-marketing Safety Planning, Evaluation, and Reporting
鈥ombining Safety Data at a Development Program Level鈥擠ata Collection and Study Design
鈥ow to Improve Safety Data Analysis and Reporting
鈥afety Boundaries for Data Monitoring Committees (DMCs)
鈥lanning for Effective Meta-analysis: What Constitutes Good Meta-analysis and What are the Limitations?
鈥egulatory Decision Making Based on Meta-analysis Results
鈥eta-analysis for Rare Events from Clinical Trials
鈥eta-analysis for Observational Data.
