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Bethesda North Marriott Hotel and Conference Center

2022 年 02 月 14 日 8:30 上午 - 2022 年 02 月 16 日 2:15 下午

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

FDA, United States

Business Informatics Specialist, OBI, OSP, CDER

Jonathan  Resnick, PMP

Speaker

Jonathan Resnick, PMP

FDA, United States

Project Management Officer, OBI, OSP, CDER

Seyoum  Senay, MS

Speaker

Seyoum Senay, MS

FDA, United States

Supervisory Operations Research Analyst, CDER/OBI

Ethan  Chen, MBA, MS, PMP

Speaker

Ethan Chen, MBA, MS, PMP

FDA, United States

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

Daniil  Graborov, MS, PMP

Speaker

Daniil Graborov, MS, PMP

FDA, United States

Computer Scientist, CDER/OBI

Norman  Schmuff, PhD

Norman Schmuff, PhD

FDA, United States

Associate Director for Science, OPMA, OPQ

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