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Electronic Standardized Study Data: Regulatory Considerations
Session Chair(s)
Mary Ann Slack
Director, Office of Strategic Programs, CDER
FDA, United States
This forum will provide an update on the standardized study data guidance and the regulatory impact of the Food and Drug Administration Safety and Innovation Act (FDASIA) on the requirement to submit study data in conformance with standards.
Learning Objective : Describe current guidance on electronic standardized study data; Discuss the eStudy data guidance and its regulatory impact on submissions.
Speaker(s)
New Regulatory Guidance on Standardized Study Data
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA Perspective
Steve Wilson, PhD
FDA, United States
Senior Staff Fellow, OB, OTS, CDER
Panelist
Mitra Rocca, MSc
FDA, United States
Associate Director, Medical Informatics, Office of Translational Science, CDER
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