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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 2: FDA Plenary

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior Advisor, Office of Regulatory Operations, CBER

FDA, United States

The FDA Plenary session is focused on presenting subject matter experts and topics related to the theme of the RSIDM: the organization, submission, and management of regulatory data and information. This session will present updates on: Data Standards, Structured Product Labeling (SPL) exchange format to Fast Healthcare Interoperability Resource format project, and FDA’s study data technical rejection initiative.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Examine the key data standards projects at FDA
  • Describe the status of the SPL to FHIR initiative
  • Identify the key components of the study data technical rejection initiative


Ray  Wang, MBA, MS

Update on FDA Data Standard Program

Ray Wang, MBA, MS

FDA, United States

Director, Data Standards Staff, OSP, CDER

G. Scott  Gordon, PhD

Update on SPL to FHIR

G. Scott Gordon, PhD

FDA, United States

Senior Health Informatics Officer, OSP, CDER

Ethan  Chen, MBA, MS, PMP

Update on Study Data Technical Rejection

Ethan Chen, MBA, MS, PMP

FDA, United States

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER

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