DIA 2018 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-545-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

William Houser

Speaker

BioCelerate Toxicology Data-Sharing Initiative: Development of a Centralized, Searchable Preclinical Data Repository
William Houser

US Regulatory Compliance With the Standard For Exchange of Nonclinical Data (SEND)
Kaitlyn Nicole Riffel, MSc