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Virtual

Feb 08, 2021 10:00 AM - Feb 10, 2021 4:30 PM

(Eastern Standard Time)

Regulatory Submissions, Information, and Document Management Forum

Session 12: Ask the Regulators

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 regulators questions. Submit your questions in advance in the Virtual Forum Platform by navigating to the session, clicking on “Polls” then enter your question for the speakers. You can also email AsktheRegRSIDM@DIAglobal.org. Please note: due to the high volume of questions, not all will be answered live at the forum

Speaker(s)

Ethan  Chen, MBA, MS, PMP

Panelists

Ethan Chen, MBA, MS, PMP

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

Ron  Fitzmartin, MBA

Panelists

Ron Fitzmartin, MBA

Principal Consultant, Decision Analytics, United States

Ginny  Hussong

Panelists

Ginny Hussong

Branch Chief, Data Standards, CBER, FDA, United States

Jonathan  Resnick, PMP

Panelists

Jonathan Resnick, PMP

Advisor, Office of Digital Transformation, FDA, United States

Mary Ann  Slack

Panelists

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA, United States

Norman  Schmuff, PhD

Panelists

Norman Schmuff, PhD

, Retired, United States

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