CBER held a discussion on CBER’s support and requirement starting March 15, 2023, 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.
Timestamps
03:50 – Study Data Standards Update for CBER: Your Guide to a Successful Submission
12:20 – Clinical Data: CBER Study Data Standards Validation Process
22:00 – Q&A Discussion Panel
Speakers:
Lisa Lin
Study Data Standards Manager
Data Standards Branch
Office of Regulatory Operations | CBER | FDA
Gabriela Lopez Mitnik
Project Manager
Data Standards Branch
Office of Regulatory Operations | CBER | FDA
Learn more at: [ Ссылка ]
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