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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

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

Speaker(s)

Ta-Jen  Chen, MS

Speaker

Ta-Jen Chen, MS

FDA, United States

Project Management Officer, OSP, CDER

Suranjan  De, MBA, MS

Speaker

Suranjan De, MBA, MS

FDA, United States

Deputy Director, Regulatory Science, OSE, CDER

Ron  Fitzmartin, PhD, MBA

Speaker

Ron Fitzmartin, PhD, MBA

FDA, United States

Senior Advisor, Office of Regulatory Operations, CBER

Ginny  Hussong

Speaker

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

Mark A. Gray

Speaker

Mark A. Gray

FDA, United States

Senior Project Manager, DSB, CBER

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