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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Session 4: FDA: Ask the Regulators – Part 1

Session Chair(s)

Ethan  Chen, MBA, MS, PMP

Ethan Chen, MBA, MS, PMP

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

Dedicated to sharing the latest information on new guidance’s, 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. We encourage participants to consider the regulators' backgrounds and expertise when directing their questions to ensure a more tailored and focused discussion.

Speaker(s)

Sri  Mantha, MBA, MS

Speaker

Sri Mantha, MBA, MS

Acting Chief Information Officer, FDA, United States

Jessica  Bernhardt, MS

Speaker

Jessica Bernhardt, MS

IT Project Manager ODT, FDA, United States

Ginny  Hussong

Speaker

Ginny Hussong

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

Ron  Fitzmartin, MBA

Speaker

Ron Fitzmartin, MBA

Principal Consultant, Decision Analytics, United States

Y. Veronica  Pei, MD, MPH

Speaker

Y. Veronica Pei, MD, MPH

Deputy Division Director, FDA, United States

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