Foundational (Basic)
Practical
Tom Steinbach, DVM, DACVP, DABT
Vice President
EPL, Inc.
Apex, North Carolina, United States
Daniel Patrick, DVM, DACVP, DABT
Executive Director
Pathology
Eli Lilly and Company, Inc.
Deb Tokarz, DVM, PhD, DACVP
Senior Pathologist
EPL, Inc.
Raleigh, North Carolina, United States
Paul Snyder, DVM, DACVP, PhD
EPL, Inc.
Ft. Myers, Florida, United States
Ines Pagan, DVM, PhD
Senior Toxicologist
CDER
US FDA
Baltimore, Maryland, United States
Educational Co-Support Provided by: EPL, Inc. and American College of Toxicology
Pathology is one of the most critical pieces in a toxicology report and so communicating with the pathologist is essential to understanding a toxicology study. The pathology report is the primary means by which the study pathologist communicates the histopathological findings and how those findings relate to other data from the study including organ weights, clinical pathology findings, macroscopic (gross) and in-life observations. In addition, the pathology peer review and a pathology working group are additional steps that can be taken to improve or clarify the findings in a toxicology study. This session will cover how a toxicologist should approach the pathology report to be able to critically review the data and the narrative. It will also cover the peer review process, how it is performed, and when best to perform a peer review and then introduce the concepts of a pathology working group and what problems a PWG can and cannot address. Finally, the session will end with a regulatory perspective on the pathology report, the peer review, and the pathology working group.
CE Course Chair: Tom Steinbach, DVM, DACVP, DABT – EPL, Inc.
CE Course Speaker: Deb Tokarz, DVM, PhD, DACVP – EPL, Inc.
CE Course Speaker: Daniel Patrick, DVM, DACVP, DABT – Eli Lilly and Company, Inc.
CE Course Speaker: Tom Steinbach, DVM, DACVP, DABT – EPL, Inc.
CE Course Speaker: Paul Snyder, DVM, DACVP, PhD – EPL, Inc.
CE Course Speaker: Ines Pagan, DVM, PhD – US FDA