Back to Agenda
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)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
New Regulatory Guidance on Standardized Study Data
Steve Wilson, PHD
Senior Staff Fellow, OB, OTS, CDER, FDA, United States
FDA Perspective
Mitra Rocca, MSC
Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Panelist
Have an account?