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Electronic Standardized Study Data: Regulatory Considerations

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
289

Room Number:
30CD

Level:
Intermediate

Type:
Forum

Title:
Electronic Standardized Study Data: Regulatory Considerations

Chair(s):
Mary Ann Slack
Deputy Director, Office of Strategic Programs, CDER
FDA, United States

Description:
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(s):
Describe current guidance on electronic standardized study data; Discuss the eStudy data guidance and its regulatory impact on submissions.

Presentation(s) & Speaker(s):
New Regulatory Guidance on Standardized Study Data
Ron Fitzmartin, PhD, MBA
Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER
FDA, United States

FDA Perspective
Stephen E. Wilson, DrPH
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
FDA, United States

Panelist
Mitra Rocca, MS
Senior Medical Informatician, Office of Translational Science, CDER
FDA, United States