Loading…
Tuesday, June 25 • 2:00pm - 3:15pm
#259: FDA Data Standards Update

Sign up or log in to save this to your schedule and see who's attending!

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-611-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA CDER and CBER implemented a joint data standards strategy in 2018, with a supporting action plan that is a PDUFA VI commitment. This session will focus on accomplishments and challenges.

Learning Objectives

Explain current and emerging data standards at FDA; Describe the FDA's data standards process and collaborations with stakeholders.

Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

CBER Study Data Standards Update
Wei (Lisa) Lin, MBA, PMP

CDER Update
Ethan Chen, MBA

CDER Update
Ta-Jen Chen, MS

CDER Update
Vaishali Popat, MD, MPH



Speakers
avatar for Ethan Chen

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA
Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led the several critical initiatives as the CDER... Read More →
TC

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Sr. Informatics Advisor, FDA
Ron Fitzmartin is Senior Project Manager, Office of the Director, 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 submissions... 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 Vaishali Popat

Vaishali Popat

Associate Director of Biomedical Informatics and Safety Analytics, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as staff training on the use of new review tools to make the evaluation of pre-marketing data... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA