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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 11: FDA - Ask the Regulators

Session Chair(s)

Mark A. Gray

Mark A. Gray

Senior Project Manager, DSB, CBER, FDA, United States

Dedicated to sharing the latest information on new guidances, this session will allow open discussion between the audience and an esteemed panel of regulatory experts. This session provides attendees the opportunity to ask regulators questions directly.

Please note: due to the high volume of questions, not all will be answered live at the forum

Speaker(s)

Heather  Crandall, MA

Speaker

Heather Crandall, MA

Business Informatics Specialist, OBI, FDA, FDA, United States

Jonathan  Resnick, PMP

Speaker

Jonathan Resnick, PMP

Advisor, Office of Digital Transformation, FDA, United States

Seyoum  Senay, MS

Speaker

Seyoum Senay, MS

Supervisory Operations Research Analyst, CDER/OBI, FDA, United States

Ethan  Chen, MBA, MS, PMP

Speaker

Ethan Chen, MBA, MS, PMP

Director, Division of Data Management , FDA CDER, United States

Daniil  Graborov, MS, PMP

Speaker

Daniil Graborov, MS, PMP

Computer Scientist, CDER/OBI, FDA, United States

Norman  Schmuff, PhD

Norman Schmuff, PhD

, Retired, United States

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