viernes, 22 de noviembre de 2019

TODAY at 1:00 p.m. CDER SBIA Webinar: The FDA Study Data Technical Conformance Guide v4.4 - Friday, Nov. 22, 2019



CDER Small Business and Industry Assistance (SBIA) Webinar
TODAY
1:00 p.m. - 2:30 p.m. Eastern
This webinar is FREE.
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

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