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Monday, June 28 • 4:00pm - 5:00pm
#146 SL: Driving Innovation in Data Standards and Regulatory Submissions at FDA

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-550-L04-P; CME 1.00; IACET 1.00; RN 1.00

The FDA session will focus on data strategy and data standards initiatives, e.g., SPL to FHIR, IDMP, RWD, CDISC Study Data, HL7 Vulcan, Technology Modernization.

Learning Objectives

Explain current and emerging data standards; Describe activities underway in the areas of data standards and regulatory submissions; Explain the FDA data strategy.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

Panelist
Mitra Rocca, MSc

Panelist
Brenda Baldwin, PhD

Panelist
Ta-Jen Chen, MS


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 Brenda Baldwin

Brenda Baldwin

Microbiologist/Primary Reviewer, OVRR/DVRPA, CBER, FDA, United States
Dr. Baldwin is a Primary Reviewer in the Office of Vaccines Research and Review (OVRR) at the FDA. In addition to her review activities, Dr. Baldwin has become the leading expert in OVRR on the use of clinical study standardized data. Dr. Baldwin’s involvement with CDISC began in... 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 Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →

Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session