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Session 2: FDA Plenary
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics 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
Speaker(s)
Update on FDA Data Standard Program
Ray Wang, MBA, MS
FDA, United States
Director, Data Standards Staff, OSP, CDER
Update on SPL to FHIR
G. Scott Gordon, PhD
FDA, United States
Senior Health Informatics Officer, OSP, CDER
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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