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FDA Study Data Technical Conformance Guide (Part 1 of 2): An Overview
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
This session will provide an overview of the FDA supplements guidance “Providing Regulatory Submissions in Electronic Format--Standardized Study Data” and provides recommendations on submitting standardized study data using FDA-supported data standards specified in the Standards Catalog.
Part 2 will take place on Tuesday, at 1:30pm (Session #258).
Learning Objective : Discuss the purpose of the Study Data Technical Conformance Guide (Guide) for data standards; Identify how to use the Guide to aid in the submission of animal and human study data in a standardized electronic format in Investigational New Drugs (IND), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and Biologic License Applications (BLA); Discuss the Study Data Reviewer's Guide and the Study Data Standardization Plan.
Speaker(s)
Statistical Perspective
Steve Wilson, PhD
FDA, United States
Senior Staff Fellow, OB, OTS, CDER
Clinical Perspective
Eileen E. Navarro Almario, MD, MS, FACP
FDA, United States
Lead Physician
eSub Perspective
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
Industry Perspective
Scott A. Getzin
Eli Lilly and Company, United States
Consultant, Data Sciences - Clinical Data Flow and Technologies
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