Abstract
This continuing education course presented at the Society of Toxicologic Pathology’s 31st Annual Symposium explored and defined the many roles that toxicologic pathologists serve Good Laboratory Practice (GLP)-conducted toxicology and carcinogenicity studies.
Keywords
This opportunity for continuing education was meant to explore and define the many roles that toxicologic pathologists serve Good Laboratory Practice (GLP)-conducted toxicology and carcinogenicity studies. The session provided a summary of the many different tasks performed by pathologists throughout differing stages of evaluations, described expectations of each phase of pathology review, and explored their relationships with the Study Director, Sponsor, and other pathologists. Also discussed was the issue of what constitutes study raw data and what is to be included in the toxicology report. The roles of the study pathologist, peer-review pathologists, pathology working group (PWG) chairperson, and participants of PWGs or Scientific Advisory Panels (SAPs) were detailed along with the applicable GLP regulations and best practices for pathology evaluations by Klaus Weber, Rick Hailey, Peter Mann, and Mark Seaton. Mark Seaton’s presentation on the interactions of pathologists and the regulatory agencies was delivered by webinar. All of the speakers have elaborated on this brief introduction or provided final perspectives on their topics in the following articles.