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Session 5: FDA - Ask the Regulators Part 1
Session Chair(s)
Mark A. Gray
Senior Project Manager, DSB, CBER, 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 electronic submission process and validation questions, with a focus on the Electronic Submissions Gateway, eCTD, and study data requirements. Questions submitted from attendees may focus on the sessions held during this forum, but can also branch out into other areas. Submit your questions in advance advance via the Mobile App by selecting “Question & Answer” in the bottom toolbar or email:AsktheRegRSIDM@DIAglobal.org. Please note: due to the high volume of questions, not all will be answered live at the forum.
Speaker(s)
Ethan Chen, MBA, MS, PMP
Director, Division of Data Management , FDA CDER, United States
Speaker
Valerie Marie Gooding
Project Management Officer, OBI, OSP, CDER, FDA, United States
Speaker
Wei (Lisa) Lin, MBA, PMP
Study Data Standards Manager, Office of Director, CBER, FDA, United States
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
Speaker
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