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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)
BioCelerate Toxicology Data-Sharing Initiative: Development of a Centralized, Searchable Preclinical Data Repository
William Houser
Bristol-Myers Squibb, United States
Capability Manager
US Regulatory Compliance With the Standard For Exchange of Nonclinical Data (SEND)
Kaitlyn Riffel, MSc
PPD, United States
Associate Director, Regulatory Affairs
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