ACT Signature Webinars

Pathology Peer Review and the OECD Guidance on the GLP Requirements: A Review of the Review 

12-21-2015 11:09 AM

Speakers: Jim Fikes, Director, Biogen Idec and Dan Patrick, Director of Pathology, MPI Research, Inc.

In collaboration with: British Toxicology Society, and the Society of Toxicologic Pathology

Pathology peer review is a fundamental process in nonclinical research that can help ensure the quality and accuracy of pathology results. Although there is no absolute requirement in the GLP principles (OECD 1998) or FDA GLP regulations (U.S. FDA 21 CFR 58) to conduct peer review, it is routinely practiced by contract research organizations and biopharmaceutical companies, and some level of peer review is generally expected by regulatory authorities. The Organisation for Economic Co-operation and Development (OECD) recently released guidance no. 16, “Guidance on the GLP Requirements for Peer Review of Histopathology.” The stated purpose was to provide guidance to pathologists, test facility management, study directors, and QA personnel on how peer review should be planned, managed, documented, and reported in order to meet GLP expectations. Since some sections were considered subject to various interpretations, the Society of Toxicologic Pathology, in collaboration with other international societies of toxicologic pathology, published a unified global review and interpretation of this guidance (Toxicol Pathol, 43: 907-914, 2015). This webinar will provide a concise and potentially useful high-level summary of the global consensus view and interpretation regarding the OECD guidance on the GLP requirements for pathology peer review.

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