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Japanese Safety Pharmacology Society

Japanese Safety Pharmacology Society. Meeting of Promoters September 5 th , 2009 Keiji Yamamoto, DVM, MBA, PhD. K. Yamamoto (Takeda Pharmaceutical) M. Tabo (Chugai) T. Kitayama (Kyowahakko-Kirin) H. Tashibu (Dainippon-Sumitomo) C, Kasai (Astellas) S. Toyoshima (Ootsuka)

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Japanese Safety Pharmacology Society

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  1. Japanese Safety Pharmacology Society Meeting of Promoters September 5th, 2009 Keiji Yamamoto, DVM, MBA, PhD

  2. K. Yamamoto (Takeda Pharmaceutical) • M. Tabo (Chugai) • T. Kitayama (Kyowahakko-Kirin) • H. Tashibu (Dainippon-Sumitomo) • C, Kasai (Astellas) • S. Toyoshima (Ootsuka) • M. Wasaki (Mitsubishi-Tanabe) • T. Hombo (Ina Research) • K. Chiba (Daiichi-Sankyo) • S. Hayashi (Nippon Shinyaku) • 6 Observers Attendees – a total of 16

  3. Japanese Safety Pharmacology Society (JSPS) • Agreed to establish as an independent and non-profit organization • Main activity is to hold an annual meeting • may develop cooperative relationship with other societies • Safety Pharmacology Society • Japan Society of Toxicology • Japanese Society of Pharmacology Name, Organization

  4. Pharmaceutical companies (~10) • CROs (~3) • Academia (~3) • Dr. Hashimoto (Yokohama Yakka Univ) • Dr. Tsubone (Tokyo Univ) • Dr. Sugiyama (Yamanashi Univ) • Regulatory agency (at least 1) • Dr. Ohno (NIHS) • Dr. Nakazawa (NIHS) • ?? (PMDA) • Rules will be revised in 2 years BoD members

  5. Annual meeting in Japan. • The 1st meeting will be in February 2010 • 50-100 attendees expected • 2.5 SPs/industry x 30 companies • 1 Toxs/industry x 30 companies • 10 persons from Academia • 5 persons from Regulatory (invited) Main activity

  6. Scientific session (Oral only?) • Symposium • Merge toxicity study with safety pharmacology studies: Why, When, Who and How? • Need mutual education between Tox- & SP gists • New tools for safety pharmacology: • iPS, Non-invasive SP methods • Disease model for risk in specific patient population Meeting Topics

  7. Regulatory session • ICH guidelines (S6, S9, E14 and S7B, M3 and vaccine) • An official guide book for ICH guidelines will be published in June 2010 (Activity has started since June 2009 NIHS/PMDA/JPMA) Topics (continued)

  8. K. Yamamoto will explain the situation in Japan in the coming SPS meeting. Relation with SPS

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