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FDA Study Data Technical Conformance Guide (Part 2 of 2): An Interactive Q&A Session
Session Chair(s)
Douglas L. Warfield, PhD
Interdisciplinary Scientist, DDMSS, OBI, OSP, CDER
FDA, United States
This FDA guide supplements the 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. In this forum, the panelists will participate in an interactive Q&A with the audience.
Part 1 will take place on Tuesday, at 10:30am (Session #233).
Learning Objective : Discuss the purpose of the Study Data Technical Conformance Guide (Guide) for Data Standards; Describe 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)
Panelist
Benjamin Peter Behrang Vali, MS
FDA, United States
Regulatory Affairs Officer and Project Manager, DGIEP, OND, CDER
Panelist
Helena Sviglin, MPH
FDA, United States
Data Standards Advisor, FDA CDER Office of Strategic Programs
Panelist
Wei (Lisa) Lin, MBA, PMP
FDA, United States
Study Data Standards Manager, Office of Director, CBER