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FDA Data Standards Update
Session Chair(s)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
FDA CDER and CBER implemented a joint data standards strategy in 2018, with a supporting action plan that is a PDUFA VI commitment. This session will focus on accomplishments and challenges.
Learning Objective : Explain the FDA data standards program; Outline some of the key data standards projects at FDA; Define biocompute objects related to SARS CoV-2.
Speaker(s)
Wei (Lisa) Lin, MBA, PMP
Study Data Standards Manager, Office of Director, CBER, FDA, United States
CBER Study Data Standards Update
Ethan Chen, MBA, MS, PMP
Director, Division of Data Management , FDA CDER, United States
CDER Update
Ta-Jen Chen, MS
Project Management Officer, OSP, CDER, FDA, United States
CDER Update
Vaishali Popat, MD, MPH
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States
CDER Update
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