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Session 2: FDA Plenary
Session Chair(s)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, 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)
Ray Wang, MBA, MS
Director, Data Standards Staff, OSP, CDER, FDA, United States
Update on FDA Data Standard Program
G. Scott Gordon, PHD
Senior Health Informatics Officer, OSP, CDER, FDA, United States
Update on SPL to FHIR
Ethan Chen, MBA, MS, PMP
Director, Division of Data Management , FDA CDER, United States
Update on Study Data Technical Rejection
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