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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 7:00 PM - Feb 13, 2019 8:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Agenda

Day 1 Feb 11, 2019

1:25 PM — 2:00 PM

Session 1: Keynote Address

2:45 PM — 4:00 PM

Session 2: Plenary Session on IDMP

4:10 PM — 5:25 PM

Session 3: Other Regions Update

Day 2 Feb 12, 2019

7:30 AM — 8:30 AM

RIM Working Group Open House

8:30 AM — 9:45 AM

Session 4: FDA – Electronic Submissions

9:55 AM — 10:45 AM

Session 5: FDA - Ask the Regulators Part 1

Day 3 Feb 13, 2019

1:15 PM — 2:00 PM

Session 11: FDA - Ask the Regulators Part 2– Standards for Product Quality, IDMP, and ICSRs

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