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Session 4: FDA – Electronic Submissions
Session Chair(s)
Ethan Chen, MBA, MS, PMP
Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
FDA, United States
Learning Objective : At the conclusion of this session, participants should be able to:
Speaker(s)
Technical Rejection Criteria for Study Data
Ethan Chen, MBA, MS, PMP
FDA, United States
Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
eCTD Submission Metrics and Guidance Update
Jonathan Resnick, PMP
FDA, United States
Project Management Officer, OBI, OSP, CDER
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