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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

FDA, United States

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

Ron  Fitzmartin, PhD, MBA

Panelists

Ron Fitzmartin, PhD, MBA

FDA, United States

Senior Informatics Advisor, Office of Regulatory Operations, CBER

Ginny  Hussong

Panelists

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

Jonathan  Resnick, PMP

Panelists

Jonathan Resnick, PMP

FDA, United States

Project Management Officer, OBI, OSP, CDER

Mary Ann  Slack

Panelists

Mary Ann Slack

FDA, United States

Director, Office of Strategic Programs, CDER

Norman  Schmuff, PhD

Panelists

Norman Schmuff, PhD

FDA, United States

Associate Director for Science, OPMA, OPQ

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