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Session 4: FDA: Ask the Regulators – Part 1
Session Chair(s)
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)
Speaker
Sri Mantha, MBA, MS
Acting Chief Information Officer, FDA, United States
Speaker
Jessica Bernhardt, MS
IT Project Manager ODT, FDA, United States
Speaker
Ginny Hussong
Branch Chief, Data Standards, CBER, FDA, United States
Speaker
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
Speaker
Y. Veronica Pei, MD, MPH
Deputy Division Director, FDA, United States
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