- December 4, 2020
This webinar is to discuss Center for Biologics Evaluation and Research’s (CBER’s) support and requirement for the Standard for the Exchange of Nonclinical Data (SEND), which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog. FDA will discuss the background of the new requirement and how SEND will aid CBER reviewers.
- Regulatory affairs professionals working on non-clinical data submission for Biologics License Applications (BLA) or Investigational New Drug (IND) applications
- Foreign regulators
- Consultants focused on non-clinical data submission
- Drug development professionals specializing in non-clinical data
- CBER requirement and support date for SEND
- Pilot studies report
- Important data points for CBER non-clinical studies
- Reviewer perspective
Data Standards Team | Office of Director | Center for Biologics Evaluation and Research (CBER) | FDA
Nabil Al-Humadi, Ph.D.
Office of Vaccine Research and Review | CBER | FDA
Susan DeHaven, MSc
Data Standards & Business Applications | Sanofi US
- Federal Register Notice – Support for Standard for the Exchange of Nonclinical Data
- FDA Data Standards Catalog
Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:
- has been pre-approved by RAPS as eligible for up to 4 credits towards a participant’s RAC recertification upon full completion.
- has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
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