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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
Director, Data Standards Staff, OSP, CDER, FDA, United States
SEND @ CBER
Study Data Standards Manager, Office of Director, CBER, FDA, United States
Identification of Medicinal Products
Project Management Officer, OSP, CDER, FDA, United States
BioCompute Objects and One Related to SARS CoV-2
Associate Director for Risk Assessment, OBE, CBER, FDA, United States
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