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  4. Common Issues with SEND Data Submitted for Safety Pharmacology Studies - 11/16/2023
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Virtual | Virtual

Event Title
Common Issues with SEND Data Submitted for Safety Pharmacology Studies
November 16, 2023

Date:
November 16, 2023
Time:
1:00 PM - 2:30 PM ET

Topic & Presentations

Speakers

Common Issues with SEND Data Submitted for Safety Pharmacology Studies

 

Background

Jesse Anderson, MPH
Team Lead, Services Team
Division of Regulatory Review and Research (DRRR)
Office of Computational Science (OCS)
Office of Translational Sciences (OTS) | CDER | FDA

OCS Nonclinical Services Overview

Benita Dharmaraj, MD., MHA
Project Manager, OCS Nonclinical Services
DRRR | OCS | OTS | CDER | FDA

Common Data Issues for SENDIG v3.1

Jennifer Feldmann, MS
OCS Contractor, SEND Subject Matter Expert
IBM | OCS | OTS | CDER | FDA

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ABOUT THIS EVENT

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.

INTENDED AUDIENCE

  • 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
  • Staff of Standards Developing Organizations responsible for Implementation Guides for use by the Pharmaceutical Industry

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

FDA RESOURCES

Event Materials

Title File Type/Size
Common Issues with SEND Data Submitted for Safety Pharmacology Studies.pdf pdf (938.74 KB)
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