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
•Challenges and Opportunities to Improve Pre-marketing Safety Planning, Evaluation, and Reporting
•Combining Safety Data at a Development Program Level—Data Collection and Study Design
•How to Improve Safety Data Analysis and Reporting
•Safety Boundaries for Data Monitoring Committees (DMCs)
•Planning for Effective Meta-analysis: What Constitutes Good Meta-analysis and What are the Limitations?
•Regulatory Decision Making Based on Meta-analysis Results
•Meta-analysis for Rare Events from Clinical Trials
•Meta-analysis for Observational Data.
FEATURED TOPICS
•Challenges and Opportunities to Improve Pre-marketing Safety Planning, Evaluation, and Reporting
•Combining Safety Data at a Development Program Level—Data Collection and Study Design
•How to Improve Safety Data Analysis and Reporting
•Safety Boundaries for Data Monitoring Committees (DMCs)
•Planning for Effective Meta-analysis: What Constitutes Good Meta-analysis and What are the Limitations?
•Regulatory Decision Making Based on Meta-analysis Results
•Meta-analysis for Rare Events from Clinical Trials
•Meta-analysis for Observational Data.
