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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)
CBER Study Data Standards Update
Study Data Standards Manager, Office of Director, CBER, FDA, United States
CDER Update
Director, Division of Data Management , FDA CDER, United States
CDER Update
Project Management Officer, OSP, CDER, FDA, United States
CDER Update
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States
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