martes, 7 de noviembre de 2017

CDER SBIA Webinar - Optimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update – Nov. 8, 2017

Don’t miss our LIVE webinar!
This event is FREE
To REGISTER and view Agenda: Click Here
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 Guide
-       Clinical 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.

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