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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

FDA Data Standards Update

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior 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)

Ray  Wang, MBA, MS

CBER-CDER Data Standards Program Overview

Ray Wang, MBA, MS

FDA, United States

Director, Data Standards Staff, OSP, CDER

Wei (Lisa)  Lin, MBA, PMP

SEND @ CBER

Wei (Lisa) Lin, MBA, PMP

FDA, United States

Study Data Standards Manager, Office of Director, CBER

Ta-Jen  Chen, MS

Identification of Medicinal Products

Ta-Jen Chen, MS

FDA, United States

Project Management Officer, OSP, CDER

Mark O. Walderhaug, PhD

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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