- November 27, 2018
01:30 PM - 02:30 PM EST
- Organized By:
Tuesday, November 27, 2018
1:30pm - 2:30pm (Eastern)
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.
Join us LIVE as our FDA experts (CDER and CBER) provide an overview of recent updates made to FDA’s Study Data Technical Conformance Guide (TCG). This Study Data Technical Conformance Guide 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.
- This one-hour live webinar is RAPS eligible for up to 1.0 credit towards a participant’s RAC recertification upon full completion.
- This event is SQA approved for 0.25 non-GCP or non-GLP units per 1 hour towards RQAP re-registration.
- Attendance Certificates are only available for TWO WEEKS after the event. Please note that the credit is only available for participation in the live event and not for watching the recording afterwards.
- Study Data Technical Conformance Guide (TCG)
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Standardized Study Data
For questions concerning the webinar, please contact CDER SBIA at: (866)-405-5367 | (301)-796-6707
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