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Driving Innovation in Data Standards and Regulatory Submissions at FDA
Session Chair(s)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, 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)
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
Panelist
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