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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
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
FDA, United States
Director, Data Standards Staff, OSP, CDER
SEND @ CBER
Wei (Lisa) Lin, MBA, PMP
FDA, United States
Study Data Standards Manager, Office of Director, CBER
Identification of Medicinal Products
Ta-Jen Chen, MS
FDA, United States
Project Management Officer, OSP, CDER
BioCompute Objects and One Related to SARS CoV-2
Mark O. Walderhaug, PhD
FDA, United States
Associate Director for Risk Assessment, OBE, CBER
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