Nov 24, 2015
This podcast, with Dr. James D Fikes, from Biogen, focuses on the Guidance on the GLP Requirements for Peer Review of Histopathology (guidance # 16) published on September 26, 2014 by the Economic Co-operation and Development (OECD). This guidance represents the first such guidance specifically on the process of Peer Review, which is a widely used tool to assure objectivity and accuracy of histopathology data by submitting it to peer analysis and discussion, before becoming official. This guideline is binding for regulatory filings in Europe and is expected to influence practices of other regulatory agencies. The Society of Toxicology Pathology, through its Scientific and Regulatory Committee, undertook a thorough analysis and provided further interpretation of this guideline in order to assist toxicologic pathologists and other scientists interested in the development of medicines, so that the guidance is better implemented in a unified fashion. This guidance clarifies some concepts, such as what is raw data in pathology contributions, and also defines the practices necessary to make this whole process officially acceptable. Dr. Fikes, as the principal author of the publication, represents the Committee’s thinking, and further discusses the impact that this guidance may have outside the OECD countries.