How to Submit Non-Clinical Data to CBER Using SEND : Understanding New FDA Requirements

What You Will Learn

The FDA’s CBER will begin requiring electronic submissions of nonclinical data to be submitted using the 3.1 and 3.1.1 versions of CDISC SENDIG on March 15th, 2023. With these requirements taking effect soon, Sponsors need to understand how to meet the new rules and regulations provided by SEND, as failing to meet them could result in FDA refusal.

In this webinar, a cross-functional team of statistical programmers and regulatory experts will share actionable insights to help study teams prepare for the new requirements.

Attendees will learn about:

• Understand nonclinical study data submissions to CDER and CBER
• Differentiate biologics from drug submission in non-clinical studies
• Prepare for this change to ensure a successful submission.
• Solve the challenges of a SEND package
• Ensure compliance with both SEND 3.1 and 3.1.1 for submission of nonclinical data to CDER and CBERHo
• Separate SEND IG DART 1.1 from SEND IG
• Manage legacy studies and studies that already meet requirements
• Differentiate between submission packages
• Use the FDA’s data standard catalog, technical conformance guide and controlled terminology

Who Will Benefit from Attending?

• Regulatory Affairs and Submissions Professionals
• Pharmaceutical Data and Programming Professionals
• Nonclinical/Preclinical Development Professionals