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Tuesday, June 16 • 2:00pm - 3:00pm
#236 L: FDA Data Standards Update

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-637-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

Explain the FDA data standards program; Outline some of the key data standards projects at FDA; Define biocompute objects related to SARS CoV-2.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

CBER-CDER Data Standards Program Overview
Ray Wang, MBA, MS

SEND @ CBER
Wei (Lisa) Lin, MBA, PMP

Identification of Medicinal Products
Ta-Jen Chen, MS

BioCompute Objects and One Related to SARS CoV-2
Mark O. Walderhaug, PhD


Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →
avatar for Wei (Lisa) Lin

Wei (Lisa) Lin

Study Data Standards Manager, Office of Director, CBER, FDA
Lisa Lin has worked as a Study Data Standards manager at FDA CBER for over a year. Currently she is responsible for all study data standards projects in CBER, including data validation, evaluation and testing of SEND standard for CBER, data analysis tool training and support. Before... Read More →
avatar for Ta-Jen Chen

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA, United States
Mr. Chen is a project management Officer at Office of Strategic Programs, CDER, US Food and Drug Administration, where he is responsible for the development and implementation of electronic data standards for CDER regulatory review. As an FDA delegate to ICH E2B Expert Working Group... Read More →
avatar for Ray Wang

Ray Wang

Data Standards Program Lead, OSP, CDER, FDA
Ray Wang, MS, MBA leads the Data Standards Team within CDER’s Office of Strategic Programs. He is responsible for managing CDER’s Data Standards Program portfolio that covers a spectrum of projects that include Study Data, Product Quality Data, Postmarket Data standards development... Read More →
MW

Mark Walderhaug

Associate Director for Risk Assessment, OBE, CBER, FDA
Mark Walderhaug is an interdisciplinary scientist in FDA's Center for Biologics Evaluation and Research (CBER). He works in the Office of Biostatistics and Epidemiology where he is the Associate Office Director for Risk Assessment. He is currently working on incorporating the computational... Read More →

Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Forum |   09: Regulatory, Forum