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Driving Innovation in Data Standards and Regulatory Submissions at FDA
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Advisor, Office of Regulatory Operations, 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
FDA, United States
Associate Director, Medical Informatics, Office of Translational Science, CDER
Panelist
Brenda Baldwin, PhD
FDA, United States
Microbiologist/Primary Reviewer, OVRR/DVRPA, CBER
Panelist
Ta-Jen Chen, MS
FDA, United States
Project Management Officer, OSP, CDER
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