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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 Services and Solutions, OBI, OSP, CDER
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 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
FDA, United States
Senior Health Informatics Officer, OBI, CDER
Panelist
La Misha Fields, MBA
FDA, United States
IT Program Manager, Electronic Submissions Gateway, OIMT, OC
Panelist
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER
Panelist
Valerie Marie Gooding
FDA, United States
Project Management Officer, OBI, OSP, CDER
CDISC SEND @ CBER
Wei (Lisa) Lin, MBA, PMP
FDA, United States
Study Data Standards Manager, Office of Director, CBER
Panelist
Jonathan Resnick, PMP
FDA, United States
Project Management Officer, OBI, OSP, CDER
Panelist
Jiang Xu
FDA, United States
Business Informatics Specialist
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