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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 5: FDA - Ask the Regulators

Session Chair(s)

Ethan  Chen, MBA, MS, PMP

Ethan Chen, MBA, MS, PMP

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

Ginny  Hussong

Speaker

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

Ram  Iyer, MS

Speaker

Ram Iyer, MS

FDA, United States

Chief Data Officer

Sri  Mantha, MBA, MS

Speaker

Sri Mantha, MBA, MS

FDA, United States

Director, Office of Strategic Programs, CDER

Christopher  Joneckis, PhD

Speaker

Christopher Joneckis, PhD

FDA, United States

Associate Director for Review Management, CBER

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