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Virtual

Apr 14, 2021 10:00 AM - Apr 16, 2021 3:45 PM

(US Eastern Standard Time)

DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.

Agenda

Day 1 Apr 12, 2021

12:00 PM — 4:00 PM

Short Course 1: Designing, Integrating, and Analyzing RCT/RWE in Safety Decision Making

Day 2 Apr 13, 2021

10:00 AM — 2:00 PM

Short Course 2: Statistical Analyses Targeting Estimands

Day 3 Apr 14, 2021

10:00 AM — 10:45 AM

Welcome, Opening Remarks and Keynote Address: The Development and Deployment of COVID-19 Vaccines

10:45 AM — 11:00 AM

Break

11:00 AM — 12:30 PM

Session 1: COVID-19 Treatments and Vaccines: Statistical Challenges and Lessons Learned

12:30 PM — 1:30 PM

Break

1:30 PM — 3:00 PM

Session 2: Impact of COVID-19 on Clinical Trials

3:00 PM — 3:15 PM

Break

3:15 PM — 4:45 PM

Session 3: Master Protocols in the COVID-19 Pandemic and Beyond

Day 4 Apr 15, 2021

10:00 AM — 11:30 AM

Session 4: Use of Real-World Evidence for Pre-Marketing Regulatory Decision Making: Current and Future

11:30 AM — 11:45 AM

Break

11:45 AM — 1:15 PM

Session 5: New Uses of External Controls Leveraging Patient Level Data and Statistical Matching or Weighting in a Regulatory Setting

1:15 PM — 2:15 PM

Break

2:15 PM — 3:15 PM

Community Discussion of Data Science in Relation to Drug Development

3:15 PM — 3:30 PM

Break

3:30 PM — 5:00 PM

Session 6: Diversity and Inclusion

Day 5 Apr 16, 2021

10:00 AM — 11:30 AM

Senior Leaders Town Hall

11:30 AM — 12:00 PM

Break

12:00 PM — 1:30 PM

Session 7: Communicating and Estimating the Estimand: the Impact of the Estimand Framework

1:30 PM — 2:30 PM

Break

2:30 PM — 3:45 PM

Session 8: Current Issues in Adaptive Design and Evolving ICH E20 Guidance and Closing Remarks

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DIA/FDA Biostatistics Industry and Regulator Forum

Agenda

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