Regulatory Application of Standard for Exchange of Nonclinical Data (SEND)

Sponsored by: Cardinal Health Specialty Solutions

Kristene Castle, Principal Scientist, Regulatory Affairs and Product Development, Regulatory Sciences
Kaitlyn Riffel, Scientist III, Regulatory Affairs and Product Development, Regulatory Sciences

Thursday - June 23, 2016 / 1:00pm ET / 10am PT
Free Event

Standard for Exchange of Nonclinical Data (SEND) is a new formatting requirement for the submission of electronic data to the FDA. This initiative is led by the Clinical Data Interchange Standards Consortium (CDISC) with the intent to integrate clinical Study Data Tabulation Models (SDTM) into nonclinical data submissions. SEND creates structured organization and terminology for nonclinical electronic data submissions to the FDA, increasing the consistency between submissions and allowing for concise communication between the FDA and sponsors.

Implementation of the new SEND standards can be an overwhelming task due to the complexity of the data, especially when preparing large drug development programs for submission. This webinar will provide an overview of the SEND initiative, including important dates, helpful reference documents, suggestions for how and where to begin the implementation process and information as to how SEND datasets are submitted to regulatory authorities.

Learning objectives

Upon the webinar’s conclusion, you will be able to:

  • Understand the regulatory basis and timing for implementation of SEND
  • Provide key points to consider during SEND implementation
  • Understand how SEND data is submitted to regulatory authorities

Who should attend

  • Drug and biologic development companies
  • Contract research organizations
  • Individuals involved in the preparation of regulatory submissions (ie, INDs, NDAs, ANDAs and BLAs)

About the Sponsors

The Regulatory Sciences group of Cardinal Health Specialty Solutions has more than 150 regulatory consultants who are proficient in all areas of drug development. With industry and FDA training, these consultants provide strategic services to pharmaceutical, biotechnology and medical device companies to help them obtain global product approval and maintain filings throughout the entire product lifecycle.

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