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FDA Data Standards Update
Session Chair(s)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
This forum will have speakers from both CBER and CDER present on: CBER CDER Data Standards Program Overview, Identification of Medicinal Products, SEND for CBER, and biocompute objects related to SARS CoV-2 (COVID 19).
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-CDER Data Standards Program Overview
Ray Wang, MBA, MS
Director, Data Standards Staff, OSP, CDER, FDA, United States
SEND @ CBER
Wei (Lisa) Lin, MBA, PMP
Study Data Standards Manager, Office of Director, CBER, FDA, United States
Identification of Medicinal Products
Ta-Jen Chen, MS
Project Management Officer, OSP, CDER, FDA, United States
BioCompute Objects and One Related to SARS CoV-2
Mark O. Walderhaug, PhD
Associate Director for Risk Assessment, OBE, CBER, FDA, United States
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