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Facilitating Nonclinical Data-Sharing and Access Across the Industry
Session Chair(s)
William Houser
Capability Manager, Bristol-Myers Squibb, United States
This session will present an overview of the SEND components required for US FDA applications and provide a foundational understanding of how to review regulatory applications for SEND compliance. This session will present the core capabilities, use cases, and principles driving the Toxicology Data Sharing Initiative.
Learning Objective : Identify the SEND components required for US FDA applications; Apply this knowledge to review regulatory applications for SEND compliance; Assess technical and operational framework for sharing preclinical toxicology and background control data; Evaluate core principles guiding data sharing and collaboration amongst preclinical consortium participants.
Speaker(s)
William Houser
Capability Manager, Bristol-Myers Squibb, United States
Kaitlyn Riffel, MSC
Associate Director, Regulatory Affairs, PPD, United States
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