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FDA Session: Electronic Submissions and Data
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, 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
Weiya Zhang, PhD
FDA, United States
Mathematical Statistician, OB, Office of Translational Science, CDER
Results from the CDISC-SEND Fit for Use Pilot: A Structured Assessment of Nonclinical Pilot Submissions to FDA
Elaine Thompson, PhD
FDA, United States
Senior Staff Fellow, OTS, OCS, CDER
CDER Perspective
Colleen Ratliffe, MS, PMP
FDA, United States
Project Management Officer, Office of Strategic Programs, CDER
CBER Perspective
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
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