CDER SBIA Webinar: FDA Study Data Technical Conformance Guide – November 27, 2018

CDER SBIA Webinar: FDA Study Data Technical Conformance Guide – November 27, 2018

Tuesday, November 27, 2018

1:30pm - 2:30pm (Eastern)

Click HERE for agenda and registration information

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.

Resources:

FDA’s Study Data Technical Conformance Guide (TCG) (PDF - 1.3MB) 

Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Standardized Study Data (PDF - 132KB)