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Bethesda North Marriott Hotel and Conference Center

Feb 13, 2023 11:30 AM - Feb 15, 2023 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Agenda

Day 1 Feb 13, 2023

1:25 PM — 2:00 PM

Session 1: Keynote Address

2:45 PM — 4:00 PM

Session 2: FDA Plenary: PDUFA VII Information Technology and Bioinformatics

4:10 PM — 5:00 PM

Session 3: FDA: Ask the Regulators

Day 2 Feb 14, 2023

8:00 AM — 9:15 AM

Session 4: FDA Plenary: Electronic Submissions Update

9:25 AM — 10:40 AM

Session 5: International Regulatory Authority Updates

10:45 AM — 11:15 AM

3:30 PM — 4:15 PM

Day 3 Feb 15, 2023

1:15 PM — 2:00 PM

Session 11: FDA - Ask the Regulators

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