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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

Session 11: FDA - Ask the Regulators

Session Chair(s)

Ethan  Chen, MBA, MS, PMP

Ethan Chen, MBA, MS, PMP

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER

FDA, United States

Dedicated to sharing the latest information on new guidance’s, 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)

Jonathan  Resnick, PMP

Speaker

Jonathan Resnick, PMP

FDA, United States

Project Management Officer, OBI, OSP, CDER

Lina  Cong, MS

Speaker

Lina Cong, MS

FDA, United States

Senior Health Informatics Officer, OBI, CDER

Norman  Schmuff, PhD

Speaker

Norman Schmuff, PhD

FDA, United States

Associate Director for Science, OPMA, OPQ

Seyoum  Senay, MS

Speaker

Seyoum Senay, MS

FDA, United States

Supervisory Operations Research Analyst, CDER/OBI

Mark A. Gray

Speaker

Mark A. Gray

FDA, United States

Senior Project Manager, DSB, CBER

William  Stevenson

Speaker

William Stevenson

FDA, United States

Supervisory IT Specialist

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