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DIA 2021 Global Annual Meeting
Driving Innovation in Data Standards and Regulatory Submissions at FDA
Session Chair(s)
Ron Fitzmartin, PhD, MBA
- Senior Informatics Advisor, Office of the Director, CBER
- FDA, United States
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 Objective : Explain current and emerging data standards; Describe activities underway in the areas of data standards and regulatory submissions; Explain the FDA data strategy.
Speaker(s)
Panelist
Mitra Rocca, MSc
- Associate Director, Medical Informatics, Office of Translational Science, CDER
- FDA, United States
Panelist
Brenda Baldwin, PhD
- Microbiologist/Primary Reviewer, OVRR/DVRPA, CBER
- FDA, United States
Panelist
Ta-Jen Chen, MS
- Project Management Officer, OSP, CDER
- FDA, United States