viernes, 30 de junio de 2017

CDER SBIA Webinar - Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER - July 13th 2017 - 1:00pm - 2:45pm (Eastern)

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

CDER invites you to our free LIVE webinar:
Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER
to be held on July 13th from 1:00pm – 2:45pm (Eastern).
Join us as our FDA experts provide an overview of recent updates made to FDA’s Study Data Technical Conformance Guide as well as important information and recommendations from the Center for Biologic Evaluation and Research (CBER) review staff to help you optimize your study data submission to CBER, by understanding required standards and expectations in order to aid the efficiency of the review process and avoid technical rejection.  Presentations include:
  • Updates to the Study Data Technical Conformance Guide
  • Providing Clinical Study Data to the Office of Vaccines
  • Perspectives from CBER’s Office of Compliance and Biologics Quality (OCBQ)
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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