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FDA Session: Electronic Submissions and Data
Session Chair(s)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
Study Data Standards are required in clinical and nonclinical studies that start after December 17, 2016. Technical rejection criteria will be added to the existing eCTD validation criteria to enforce the deadlines. This session will provide an update on these topics and others focused on eCTD and standardized study data.
Learning Objective : Discuss the status of electronic submissions, standardized data requirements, and data validation at FDA.
Speaker(s)
Moving Forward: Statistical Review of CDISC ADaM Standardized Data at CDER
Mathematical Statistician, OB, Office of Translational Science, CDER, FDA, United States
Results from the CDISC-SEND Fit for Use Pilot: A Structured Assessment of Nonclinical Pilot Submissions to FDA
Senior Staff Fellow, OTS, OCS, CDER , FDA, United States
CDER Perspective
Project Management Officer, Office of Strategic Programs, CDER, FDA, United States
CBER Perspective
Branch Chief, Data Standards, CBER, FDA, United States
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