Panel Discussion: Regulatory Perspective for Pathology Data (Transcript)

The Japanese Society of Toxicologic Pathology (JSTP) held a symposium entitled “Panel Discussion: Regulatory Perspective for Pathology Data” on Jan 28, 2009 during the 25th JSTP annual meeting at Hamamatsu (Jan 27–28, 2009) (Meeting President: Dr. Sunao Manabe, Daiichi Sankyo Co., Ltd., Medicinal Safety Research Labs). The purpose of the panel discussion was to clarify differences between USA, EU and Japan of 1) definition of pathological data and 2) peer review process, and subsequently trigger their harmonization, by briefly introducing the results of questionnaire survey conducted beforehand thanks to the cooperation of Japanese pharmaceutical companies and contract research organizations. (This survey was conducted in cooperation with International Federation of Societies of Toxicologic Pathologists/Regulatory Interaction Committee (IFSTP/RIC) and Japanese Society of Toxicologic Pathology.) The panel discussion was co-chaired by Dr.Yuji Oishi (Astellas Pharma Inc.) and Dr. Kazutoshi Tamura (Bozo Research Center). Panelists were Dr. Frédéric Schorsch (IFSTP/RIC, Bayer CropScience), Dr. Klaus Weber (Harlan Laboratories, Inc.), Dr.Jerry Hardisty (Experimental Pathology Laboratories, Inc.) and Mr.Jun-ichi Kuranami (the Japan Society of Quality Assurance, Kyowa Hakko Kirin). During the panel discussion, simultaneous interpretation -Japanese/Englishwas provided. This transcript of the panel discussion is published in the Journal of Toxicologic Pathology with the approval of the 25th JSTP Meeting President and the board of directors of JSTP.