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FDA Data Standards Update
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, 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
Wei (Lisa) Lin, MBA, PMP
FDA, United States
Study Data Standards Manager, Office of Director, CBER
CDER Update
Ethan Chen, MBA, MS, PMP
FDA, United States
Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
CDER Update
Ta-Jen Chen, MS
FDA, United States
Project Management Officer, OSP, CDER
CDER Update
Vaishali Popat, MD, MPH
FDA, United States
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER
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