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Session 2: FDA Opening Plenary Panel: PDUFA VI Informatics
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
This session will provide an overview of the FDA electronic submission systems and data standards that impact sponsors applications from time of submission at the ESG through the time the submission is made available to the review team. In addition, receive an update on the CBER-CDER Joint Data Standards Strategy and Action Plan, and the Public Meeting scheduled for March 2018.
Speaker(s)
Electronic Submissions Gateway Update
La Misha Fields, MBA
FDA, United States
IT Program Manager, Electronic Submissions Gateway, OIMT, OC
Data Standards Strategy and Action Plan Update
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
Electronic Submissions Update
Ethan Chen, MBA, MS, PMP
FDA, United States
Director, Division of Data Management Services and Solutions, OBI, OSP, CDER