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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 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

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 Services and Solutions, OBI, OSP, CDER

FDA, 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.


Sri  Mantha, MBA, MS


Sri Mantha, MBA, MS

FDA, United States

Director, Office of Strategic Programs, CDER

Jessica  Bernhardt, MS


Jessica Bernhardt, MS

FDA, United States

ESG Program Manager

Ginny  Hussong


Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

Ron  Fitzmartin, PhD, MBA


Ron Fitzmartin, PhD, MBA

FDA, United States

Senior Advisor, Office of Regulatory Operations, CBER

Y. Veronica  Pei, MD, MEd, MPH


Y. Veronica Pei, MD, MEd, MPH

FDA, United States

Acting Associate Director, Biomedical Informatics and Regulatory Review Science

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