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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 11: FDA - Ask the Regulators: International Panel

Session Chair(s)

Mark A. Gray

Mark A. Gray

Senior Project Manager, DSB, CBER

FDA, United States

This session provides attendees the opportunity to ask global regulators electronic submission and standardized data questions, including the regulators coordination strategy on the various initiatives. Submit your questions in advance via the Mobile App by selecting “Question & Answer” in the bottom navigation bar or email Please note: due to the high volume of questions, not all will be answered live at the forum.


Craig  Anderson


Craig Anderson

Pfizer Inc , Canada

Director, R&D Lead, International Labeling Group

Norman  Schmuff, PhD


Norman Schmuff, PhD

FDA, United States

Associate Director for Science, OPMA, OPQ

Ta-Jen  Chen, MS


Ta-Jen Chen, MS

FDA, United States

Project Management Officer, OSP, CDER

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