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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

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)

Mitra Rocca, MSc

Panelist

Mitra Rocca, MSc

  • Associate Director, Medical Informatics, Office of Translational Science, CDER
  • FDA, United States
Brenda Baldwin, PhD

Panelist

Brenda Baldwin, PhD

  • Microbiologist/Primary Reviewer, OVRR/DVRPA, CBER
  • FDA, United States
Ta-Jen Chen, MS

Panelist

Ta-Jen Chen, MS

  • Project Management Officer, OSP, CDER
  • FDA, United States