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Tommy Douglas Conference Center

02 mar 2020 7:00 a.m. - 03 mar 2020 5:15 p.m.

10000 New Hampshire Ave, Silver Spring, MD 20903

DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients

Agenda

Día 1 02 mar 2020

7:00 AM — 8:00 AM

Continental Breakfast and Networking

7:00 AM — 5:00 PM

Registration

8:00 AM — 8:30 AM

Welcome and Opening Remarks

8:30 AM — 9:00 AM

Keynote Address

9:00 AM — 10:30 AM

Session 1: PDUFA VI Pilot Program and Discussion

10:30 AM — 11:00 AM

Refreshment and Networking Break

11:00 AM — 2:15 PM

Session 2: CID - Master Protocols

12:20 PM — 1:15 PM

Luncheon and Networking

2:15 PM — 5:05 PM

Session 3: Flexible, Efficient Decision-Making: Complex Adaptive Design

3:00 PM — 3:30 PM

Refreshment and Networking Break

5:05 PM — 6:05 PM

Networking Reception

Día 2 03 mar 2020

7:00 AM — 8:00 AM

Continental Breakfast and Networking

8:00 AM — 8:10 AM

Welcome to Day Two

8:10 AM — 8:40 AM

Day 2 Keynote

8:40 AM — 11:30 AM

Session 4: Bayesian Designs: Continuous Learning and Decision-Making

9:30 AM — 10:00 AM

Refreshment and Networking Break

11:30 AM — 12:30 PM

Luncheon and Networking

12:30 PM — 3:20 PM

Session 5: Alternative Data Sources and Historical Controls

1:50 PM — 2:20 PM

Refreshment and Networking Break

3:20 PM — 4:50 PM

Session 6: Global Regulatory Affairs

4:50 PM — 5:15 PM

Closing Remarks

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DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients

Agenda

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