Author: [AUTHOR] Published on 11/15/2023 12:00:00 AM

FDA’s SBIA Announces a Webinar on Common Issues with SEND Data Submitted for Safety Pharmacology Studies

On November 16, 2023, FDA Center for Drug Evaluation and Research (CDER)’s Small Business and Industry Assistance (SBIA) will present a webinar entitled “Common Issues with SEND Data Submitted for Safety Pharmacology Studies”.

In this webinar, CDER’s Office of Computational Science (OCS) will provide updates on the KickStart service, now known as the OCS Nonclinical Services and discuss updated data quality information focusing on submitted study data conformant to the Standard Exchange for Nonclinical Data (SEND) Implementation Guide version 3.1. Industry will be able to apply this knowledge to update their systems to avoid these errors in the future to increase usability of the SEND datasets for regulatory reviewers.

Topics Covered:

• Updates to KickStart service delivery for nonclinical reviewers
• Common data findings in Clinical Data Interchange Standards Consortium - Standard for Exchange Nonclinical Data (CDISC-SEND) Datasets

Date/Time of the Webinar:

• Date: November 16, 2023
• Time: 1:00 p.m. – 2:30 p.m. ET

Additional Details:
The webinar is free, but registration is required.

The intended audience includes regulatory affairs professionals who submit SEND data to CDER for review (INDs/NDAs/ANDAs/BLAs), CROs and/or consultants preparing and reviewing SEND datasets conformant to SENDIGv3.1 for sponsors, and staff of standards developing organizations responsible for implementation guides for use by the pharmaceutical industry.

CDER’s SBIA aims to help small pharmaceutical business and industry navigate the wealth of information that FDA offers and assist in understanding human drug product regulation. To learn more about CDER’s SBIA, visit their website.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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