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Monday, June 25 • 3:00pm - 4:00pm
#147: Facilitating Nonclinical Data-Sharing and Access Across the Industry

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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


Speakers
avatar for William Houser

William Houser

Capability Manager, Bristol-Myers Squibb
William Houser is a senior research scientist for Bristol-Myers Squibb, where he has 25+ years of experience in nonclinical toxicology. He is a core team member on the BioCelerate projects for Toxicology Data and Background Control Data Sharing. For the last 10 years he has been developing... Read More →
avatar for Kaitlyn Riffel

Kaitlyn Riffel

Consultant, Scientific Consulting, Cardinal Health Regulatory Sciences
Kaitlyn Riffel is a Consultant of Global Regulatory Affairs for Cardinal Health Regulatory Sciences (CHRS) where she consults on drug, device, and biologic development. Kaitlyn holds a Master of Science in Integrative Pharmacology from Michigan State University College of Osteopathic... Read More →

Monday June 25, 2018 3:00pm - 4:00pm
Room 151AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: PreClin Dev-EarlyPhaseCR, Session