CDER SBIA Webinar: The FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019

CDER Small Business and Industry Assistance (SBIA) Webinar FDA Study Data Technical Conformance Guide v4.4 Friday, November 22, 2019 | 1:00 p.m. - 2:30 p.m. Eastern This webinar is FREE.

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Join us live as FDA experts provide an overview of recent updates made to FDA’s Study Data Technical Conformance Guide v4.4 – posted in October 2019. The Study Data TGC provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog. The TCG supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data and provides technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs. TOPICS COVERED Updates since March 2019 sdTCG Using the simplified TS.xpt Section 8.2.2 specifics There will be detailed examples of the intricacies of using the simplified TS.xpt with nonclinical submissions. INTENDED AUDIENCE Anyone involved in the collection, preparation or submission of study data to FDA. FDA SPEAKERS Helena Sviglin Study Data Technical Conformance Guide, Chair Office of Strategic Programs (OSP) | CDER | FDA Heather Crandall Electronic Submissions Team Office of Business Informatics (OBI) | CDER | FDA Stephanie Leuenroth-Quinn Nonclinical Representative for Data Standards Development Office of New Drugs (OND) | CDER | FDA