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Session Chair(s)
Mary Ann Slack
Director, Office of Strategic Programs, CDER
FDA, United States
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
Decision Analytics, United States
Principal Consultant
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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