DIA 2020 Global Annual Meeting

Agenda

Day 1 Jun 16, 2020

2:00 PM — 3:00 PM

The FDA Complex Innovative Trial Design Pilot Program: Case Examples

4:00 PM — 5:00 PM

Dynamic Multi-Disciplinary Collaboration for Aggregate Product Safety Assessment and Benefit-Risk Planning

Day 2 Jun 17, 2020

8:00 AM — 9:00 AM

Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance

4:00 PM — 5:00 PM

Using Data Monitoring Strategies in Detection of Data Anomalies and Trial Misconduct

Day 3 Jun 18, 2020

8:00 AM — 9:00 AM

Statistical Considerations for Using External Controls in Clinical Trials

9:30 AM — 10:30 AM

Opportunities and Challenges for Real World Data and Real World Evidence: Dive Into the Details

5:00 PM — 6:00 PM

ON DEMAND - Best Practices for Randomization and Re-Randomization in Clinical Trials

5:00 PM — 6:00 PM

ON DEMAND - Hype or Hope: Quantifying the Risk of Patients with Complex Diseases

5:00 PM — 6:00 PM

ON DEMAND - Replication of Randomized Controlled Trials Using Real World Data: What Does Good Look Like?

5:00 PM — 6:00 PM

ON DEMAND - Using Data Visualization to Drive Meaningful Insights

5:00 PM — 6:00 PM

ON DEMAND - Utilization of Bayesian Statistics in Clinical Trials

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