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ABOUT THIS WEBINAR

CBER will discuss 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. FDA will discuss the brief background of the new requirement and how SEND will aid CBER reviewers. The webinar will also address common issues in submission data.

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals working on clinical and non-clinical data submissions for BLAs/NDAs/ANDAs/INDs to CBER
• Consultants focused on clinical and non-clinical data submission
• Healthcare professionals specializing in clinical and non-clinical data
• Foreign regulators

TOPICS COVERED

• CBER requirement and support date for SEND
• SEND data common issues
• CBER study data standards validation process
• Clinical data common issues

FDA SPEAKERS

Lisa Lin, MBA
Study Data Standards Manager
Data Standards Branch | Office of Regulatory Operations | CBER | FDA

Gabriela Lopez Mitnik, MS, MPhil
Project Manager
Data Standards Branch | Office of Regulatory Operations | CBER | FDA

FDA RESOURCES

• Federal Register Notice regarding SEND for CBER
• FDA Data Standards Catalog
• Study Data Technical Conformance Guide
• FDA Study Data Standards Resources
• Email: cber-edata@fda.hhs.gov

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• 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.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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