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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 7:00 PM - Feb 13, 2019 8:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

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Session 11: FDA - Ask the Regulators Part 2– Standards for Product Quality, IDMP, and ICSRs

Session Chair(s)

Norman Schmuff, PhD

Associate Director for Science, OPMA, OPQ, CDER

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 will focus on PQ/CMC, IDMP, and E2B.Submit your questions in advance via the Mobile App by selecting “Question & Answer” in the bottom toolbar or email: AsktheRegRSIDM@DIAglobal.org. Please note: due to the high volume of questions, not all will be answered live at the forum.

Speaker(s)

Speaker

Ta-Jen Chen, MS

FDA, United States

Project Management Officer, OSP, CDER

Speaker

Suranjan De, MBA, MS

FDA, United States

Deputy Director, Regulatory Science, OSE, CDER

Speaker

Ron Fitzmartin, PhD, MBA

FDA, United States

Senior Advisor, Office of Regulatory Operations, CBER

Speaker

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

Speaker

Mark A. Gray

FDA, United States

Senior Project Manager, DSB, CBER

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Regulatory Submissions, Information, and Document Management Forum

Session 11: FDA - Ask the Regulators Part 2– Standards for Product Quality, IDMP, and ICSRs

Session Chair(s)

Norman Schmuff, PhD

Speaker(s)

Speaker

Speaker

Speaker

Speaker

Speaker

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