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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
FDA, United States
Director, Office of Strategic Programs
Speaker
Jessica Bernhardt, MS
FDA, United States
IT Project Manager ODT
Speaker
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
Speaker
Ron Fitzmartin, PhD, MBA
Decision Analytics, United States
Principal Consultant
Speaker
Y. Veronica Pei, MD, MEd, MPH
FDA, United States
Lead Physician, Associate Director, Biomedical Informatics and Regulatory Review