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Electronic Standardized Data in Regulatory Submissions
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
This session will provide an update on the binding standardized study data guidance and its impact on the requirement to submit study data in conformance with FDA supported standards.
Learning Objective : Discuss the binding guidance to industry on standardized study data, as well as other study data standards initiatives; Summarize FDA's efforts to develop, test and support therapeutic area data standards; Describe FDA's participation in and status of international data standards initiatives, such as Identification of Medicinal Products (IDMP).
Speaker(s)
Panelist
Colleen Ratliffe, MS, PMP
FDA, United States
Project Management Officer, Office of Strategic Programs, CDER
Panelist
Benjamin Peter Behrang Vali, MS
FDA, United States
Regulatory Affairs Officer and Project Manager, DGIEP, OND, CDER
Panelist
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER
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