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Session 5: FDA - Ask the Regulators: Electronic Submissions and eCTD Panel
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 guidances, this session will allow open discussion between the audience and an esteemed panel of regulatory experts. This session provide attendees the opportunity to ask regulators electronic submission process and validation questions. Submit your questions in advance via the Mobile App by selecting “Question & Answer” in the bottom navigation bar 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)
Panelist
Lina Cong, MS
Senior Health Informatics Officer, OBI, CDER, FDA, United States
Panelist
La Misha Fields, MBA
IT Program Manager, Electronic Submissions Gateway, OIMT, OC, FDA, United States
Panelist
Mark A. Gray
Senior Project Manager, DSB, CBER, FDA, United States
Panelist
Valerie Marie Gooding
Project Management Officer, OBI, OSP, CDER, FDA, United States
CDISC SEND @ CBER
Wei (Lisa) Lin, MBA, PMP
Study Data Standards Manager, Office of Director, CBER, FDA, United States
Panelist
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
Panelist
Jiang Xu
Business Informatics Specialist, FDA, United States
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