November 8, 2017
2:00PM - 3:30PM (Eastern)
This event is FREE
View Agenda: Click Here
The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes you to our webinar series.
These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
CDER invites you to our LIVE webinar:
Optimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update
to be held on November 8th from 2:00pm – 3:30pm (Eastern).
Join us as our FDA experts provide an overview of recent updates made to FDA’s Study Data Technical Conformance Guide. This Study Data Technical Conformance Guide (TCG) 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. Presentations include:
- Introduction to the Study Data Technical Conformance GuideClinical Outcome
- Assessments: QS Domain
- Providing SEND Data to CDER
You will have an opportunity to submit questions during a live Q and A session after the presentation.
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
Please note that the credit is only available for participation in the live
event and not for watching the recording afterwards.
For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707
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Optimizing Your Study Data Submissions to FDA âStudy Data Technical Conformance Guide October 2017
- CFR 21 Part 314
- PDUFA VI
- FDA PRO Guidance for Industry
- BEST (Biomarkers, EndpointS, and other Tools)
- FDA COA Qualification Program
- FDA TCG
- Work Productivity and Activity Impairment Questionnaire: General Health V2.0
- NCI PRO-CTCAE