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Himegin Hall
(Ehimeken Kenmin Bunka Kaikan)
2-5-1 Dogomachi, Matsuyama
Ehime 790-0843, Japan
TEL: +81-89-923-5111
FAX: +81-89-923-5112
Program
Time Schedule
日程表
日程表　1日目
日程表　2日目
日程表　3日目
Program
Presidential Lecture
December 5 (Fri) 13:50～14:20 Room 1　Main Hall, 1F, Himegin Hall
PL  
Chair： Yuichi Ohashi (Ehime University)
Speaker： Masahiro Nomoto (Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine)
Special Lecture
December 5 (Fri) 13:20～13:50 Room 1　Main Hall, 1F, Himegin Hall
SL Medical Drugs from past to future
-Expectation on Japanese Society of Clinical Pharmacology and Therapeutics-
Chair： Masahiro Nomoto (Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine)
Speaker： Akihiro Igata (Nagoya University of Arts and Sciences)
Invited Lecture
December 4 (Thu) 11:10～12:00 Room 1　Main Hall, 1F, Himegin Hall
IL Translation from preclinical studies to clinical outcome:
Focusing on the prediction of pharmacokinetic properties of drugs
Chair： Kyoichi Ohashi (Oita University)
Speaker： Yuichi Sugiyama (Sugiyama Laboratory, RIKEN Innovation Center)
Educational Lecture
December 4 (Thu) 11:10～12:00 Room 2　Sub Hall, 1F, Himegin Hall
EL1 The Collaboration between Medical and Pharmaceutical Field for Innovative Drug Development
Chair： Jitsuo Higaki (EHIME UNIVERSITY HOSPITAL)
Speaker： Gen Sobue (Department of Neurology, Nagoya University Graduate School of Medicine)
December 4 (Thu) 11:10～12:00 Room 3　Shinju A, 2F, Himegin Hall
EL2 Utilization of patient-level clinical trial data: Drug development and regulatory review
Chair： Masato Yasuhara (Tokyo Medical and Dental University)
Speaker： Yuki Ando (Pharmaceuticals and Medical Devices Agency)
December 4 (Thu) 11:10～12:00 Room 4　Shinju B, 2F, Himegin Hall
EL3 Population pharmacokinetic/pharmacodynamic analysis in clinical study
Chair： Toshiaki Sendo (Department of Clinical Pharmacy, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan)
Speaker： Ichiro Ieiri (Department of Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University)
December 4 (Thu) 11:10～12:00 Room 5　Conference room 6, 3F, Himegin Hall
EL4 Practical issues surrounding research ethics committees
Chair： Masakatsu Nishikawa (Clinical Research Support Center，Mie University Hospital)
Speaker： Masayuki Yoshida (Bioethics Research Center, Tokyo Medical and Dental University)
December 5 (Fri) 11:10～12:00 Room 1　Main Hall, 1F, Himegin Hall
EL5 Quality assurance of investigator-initiated clinical trials
Chair： Shun Higuchi (FUKUOKA UNIVERSITY Central Research Institute,
Academic, Industrial and Governmental Liaison Center)
Speaker： Yasuo Ohashi (Department of Integrated Science and Engineering for SustainableSociety, Chuo University)
December 5 (Fri) 11:10～12:00 Room 2　Sub Hall, 1F, Himegin Hall
EL6 To send unapproved or off-labeled drugs with high medical needs to patients
Chair： Tomonori Tateishi (Pharmaceuticals and Medical Devices Agency)
Speaker： Nobuko Ushirozawa (Office for Advanced Medical Care Evaluation, National Cancer Center)
December 5 (Fri) 11:10～12:00 Room 3　Shinju A, 2F, Himegin Hall
EL7 Progress of Pharmacogenomics and its Application to Clinical Pharmacology
Chair： Yoichi Hiasa (Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine)
Speaker： Takahisa Furuta (Center for Clinical Research, Hamamatsu University School of Medicine)
December 5 (Fri) 11:10～12:00 Room 4　Shinju B, 2F, Himegin Hall
EL8 The skill for CRC and PM to evaluate drug adverse events
Chair： Risako Yamashita (Clinical Therapeutic Trial Center, Ehime University Hospital)
Speaker： Hiroyuki Fukase (CPC Clinical Trial Hospital, Medipolis Medical Research Institute)
December 5 (Fri) 11:10～12:00 Room 5　Conference room 6, 3F, Himegin Hall
EL9 Off-label use of drugs in children
Chair： Yoichi Ishikawa (National Center for Child Health and Development Department of Pharmacy)
Speaker： Shinya Ito (Division of Clinical Pharmacology & Toxicology, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, CANADA)
December 5 (Fri) 11:10～12:00 Room 6　Conference room 8, 3F, Himegin Hall
EL10 Pharmaceutical Products' surplus of imports over exports in Japan
Chair： Akinobu Hamada (Department of Clinical Pharmacology, Center for Translational Research Core, National Cancer Center Research Institute)
Speaker： Masaru Nagasawa (Office of Pharmaceutical Industry Research)
December 6 (Sat) 11:10～12:00 Room 1　Main Hall, 1F, Himegin Hall
EL11 Conflict of interest in clinical research: considering its appropriate regulation
Chair： Shinichi Kawai (Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine)
Speaker： Yasushi Kodama  
December 6 (Sat) 11:10～12:00 Room 2　Sub Hall, 1F, Himegin Hall
EL12 Current status and future perspecive of pharmacovigilance in Japan: Review on published Risk Management Plans on SGLT2 inhibitors as examples
Chair： Shigeru Kageyama (Clinical Research Support Center, The Jikei University School of Medicine )
Speaker： Kiyoshi Kubota (NPO Drug Safety Research Unit Japan)
December 6 (Sat) 11:10～12:00 Room 3　Shinju A, 2F, Himegin Hall
EL13 Introduction to Biostatistics for Clinical Research
Chair： Yoshihiro Miyake (Department of Public Health, Ehime University Graduate School of Medicine)
Speaker： Takeharu Yamanaka (Department of Biostatistics, Yokohama City University)
December 6 (Sat) 11:10～12:00 Room 4　Shinju B, 2F, Himegin Hall
EL14 The Key maximizing potential of project management in clinical research
Chair： Sato Norihiro (Clinical Research and Medial Innovation Center)
Speaker： Koichi Konno (DIA Japan Project Management Community/ PM consulting Positive Intention)
December 6 (Sat) 11:10～12:00 Room 5　Conference room 6, 3F, Himegin Hall
EL15 What is missing in Japan towards internationalization of drug development?
Chair： Shinichi Kobayashi (Showa University Clinical Research Institute for Clinical Pharmacology & Therapeutics/ Showa University Hospital Clinical Trial Support Center)
Speaker： Junko Sato (Pharmaceuticals and Medical Devices Agency)
December 6 (Sat) 11:10～12:00 Room 6　Conference room 8, 3F, Himegin Hall
EL16  
Chair： Eiji Uchida (Office for Promoting Medical Research, Showa University)
Speaker： Ataru Igarashi  
Symposium
December 4 (Thu) 9:00～11:00 Room 1　Main Hall, 1F, Himegin Hall
S 1 How should medical institutes and researchers face to the revised ethical guidelines for medical/epidemiological research involving human subjects?
Chair： Toshiyuki Sasaguri (Department of Clinical Pharmacology, Faculty of Medical Sciences, Kyushu University)
  Noriko Morishita (Osaka National Hospital Division of Clinical Research Promotion Institute for Clinical Research)
December 4 (Thu) 9:00～11:00 Room 2　Sub Hall, 1F, Himegin Hall
S 2 Merits of new biomarkes for drug treatment in clinical practice
Chair： Akio Fujimura (Department of Clinical Pharmacology, Jichi Medical University)
  Miki Nakajima (Drug Metabolism and Toxicology, Faculty of Pharmaceutical Sciences, Kanazawa University)
December 4 (Thu) 9:00～11:00 Room 3　Shinju A, 2F, Himegin Hall
S 3 "Japan's NIH":The Launch of AMED (Japan Agency for Medical Research and Development)
Chair： Toshio Miyata (HPGI Executive Director)
  Naoto Uemura (Oita University and Osaka University)
December 4 (Thu) 9:00～11:00 Room 4　Shinju B, 2F, Himegin Hall
S 4 Clinical Research Network　～Aiming to establish a more functional research network in Japan
Chair： Chieko Suzuki (Center for Clinical Research, Hamamatsu University School of Medicine)
  Hideki Oi (Translational Research Informatics Center, Foundation for Biomedical Research and Innovation)
December 4 (Thu) 9:00～11:00 Room 5　Conference room 6, 3F, Himegin Hall
S 5 Clinical Pharmacology of Pharma and Food sharing Common Origin
Chair： Shizuo Yamada (The Center for Pharma and Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka)
  Yasuo Watanabe (Yokohama College of Pharmacy, General Health Medical Center)
December 4 (Thu) 9:00～11:00 Room 6　Conference room 8, 3F, Himegin Hall
S 6 Research Forefront of ion channels and transporters aiming at new drug development
Chair： Naohiko Anzai (Dept. Pharmacol. Toxicol., Dokkyo Med. Univ. Sch. Med.)
  Takahiro Iwamoto (Dept. Pharmacol., Fukuoka Univ. Sch. Med.)
December 4 (Thu) 9:00～11:00 Room 7　Conference room 11, 1F, Himegin Hall Annex
S 7 Present status of molecular-targeted agents in cancer therapy
Chair： Hirofumi Fujii (Division of Clinical Oncology, Jichi Medical University Hospital)
  Hiroaki Yanagawa (Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital)
December 4 (Thu) 16:30～18:30 Room 1　Main Hall, 1F, Himegin Hall
S 8 Tips for Investigator initiated clinical trials from planning to NDA　～successful experience learned from achieved team～
Chair： Yukiko Maruyama (Japan Medical Association Center for Clinical Trials Clinical Research Division)
  Fumiaki Kobayashi (CTD　Inc.)
December 4 (Thu) 16:30～18:30 Room 2　Sub Hall, 1F, Himegin Hall
S 9 Must-do list for boosting First-in-Human study in Japan
Chair： Yoshiaki Uyama (Office of Safety I, Pharmaceuticals and Medical Devices Agency)
  Shinji Miyake (Center for Clinical Research, Keio University School of Medicine)
December 4 (Thu) 16:30～18:30 Room 3　Shinju A, 2F, Himegin Hall
S10 Monitoring and Audit in Investigator-initiated Clinical Trials: Current Practice and Challenges
Chair： Tetsuya Nakamura (Clinical Investigation and Research Unit, Gunma University Hospital)
  Eriko Aotani (Clinical Trial Coordinating Center, Kitasato Academic Research Organization, Kitasato University)
December 4 (Thu) 16:30～18:30 Room 4　Shinju B, 2F, Himegin Hall
S11 Pharmacometrics, as a Field of Clinical Pharmacology 2 ～ Pharmacometrics is focusing beyond pharmacokinetics ～
Chair： Yuji Kumagai (Kitasato Clinical Research Center, Kitasato University)
  Naoto Hayashi (Clinical Development Center, Merck Serono Co., Ltd.)
December 4 (Thu) 16:30～18:30 Room 5　Conference room 6, 3F, Himegin Hall
S12 The importance of domestic and international collaboration in the orphan drug development
Chair： Harumasa Nakamura (Clinical Research Support Office, Translational Medical Center, National Center of Neurology and Psychiatry)
  Hiroshi Mizushima (Center for Public Health Informatics, National Institute of Public Health)
December 4 (Thu) 16:30～18:30 Room 6　Conference room 8, 3F, Himegin Hall
S13 Issues in clinical trial in mental disorders
Chair： Kazutaka Shimoda (Department of Psychiatry, Dokkyo Medical University School of Medicine)
  Norio Furukori (Department of Neuropsychiatry, Graduate Schhol of Medicine, Hirosaki University)
December 4 (Thu) 16:30～18:30 Room 7　Conference room 11, 1F, Himegin Hall Annex
S14 A New Era for Anticoagulation in Atrial Fibrillation
Chair： Naoki Matsumoto (Department of Pharmacology, St. Marianna University School of Medicine)
  Tsuyoshi Shiga (Department of Cardiology, Tokyo Women’s Medical University)
December 5 (Fri) 9:00～11:00 Room 1　Main Hall, 1F, Himegin Hall
S15 PMDA Session: Challenges for the future drug regulation
Chair： Yoshiaki Uyama (Office of Safety I, Pharmaceuticals and Medical Devices Agency)
  Hironobu Saito (New Drug Regulatory Affairs Department, DaiichiSankyo Co.,LTD)
December 5 (Fri) 9:00～11:00 Room 2　Sub Hall, 1F, Himegin Hall
S16 Findings from meta-analysis: believe or not?
Chair： Hideki Origasa (The University of Toyama School of Medicine)
  Kenichi Matsui (Showa University Office for Promoting Medical Research)
December 5 (Fri) 9:00～11:00 Room 3　Shinju A, 2F, Himegin Hall
S17 Current topics of pediatric clinical trials and drug evaluation
Chair： Hidefumi Nakamura (Division for Clinical Trials, National Center for Child Health and Development)
  Eiichi Ishii (Department of Pediatrics, Ehime University Graduate School of Medicine)
December 5 (Fri) 9:00～11:00 Room 4　Shinju B, 2F, Himegin Hall
S18 Expansion of TDM world with new technologies and opportunities for clinical pharmacology study
Chair： Kazuyuki Ueno (Niigata University of Pharmacy and Applied Sciences)
  Hirotoshi Echizen (Meiji Pharm Univ, Dept Pharmacother)
December 5 (Fri) 9:00～11:00 Room 5　Conference room 6, 3F, Himegin Hall
S19 Drug interaction, from the point of view of time
Chair： Tsutomu Kotegawa (Oasis Daiichi Hospital/Jichi Medical University)
  Ikumi Tamai (Kanazawa University, Faculty of Pharmaceutical Sciences)
December 5 (Fri) 9:00～11:00 Room 6　Conference room 8, 3F, Himegin Hall
S20 Enhancing Non-Clinical and Clinical Mutual Scientific Interpretation of Drug Safety
Chair： Masaru Iwasaki (Center for Advancing Clinical Research, University of Yamanashi)
  Yoshiro Saito (National Institute of Health Sciences)
December 5 (Fri) 9:00～11:00 Room 7　Conference room 11, 1F, Himegin Hall Annex
S21 Study coordination of Clinical Trial
Chair： Hideki Hanaoka (Chiba University Hospital Clinical Research Center)
  Hiroi Kasai (Kyoto University Hospital Institute for Advancement of Crinical and Translational Science)
December 5 (Fri) 15:40～17:40 Room 1　Main Hall, 1F, Himegin Hall
S22 Transparency of Clinical Studies
Chair： Masahiro Nomoto (Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine)
  Hiroshi Watanabe (Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine)
December 5 (Fri) 15:40～17:40 Room 2　Sub Hall, 1F, Himegin Hall
S23 Unmet medical needs in central nervous system diseases
Chair： Takashi Moritoyo (Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital )
  Masahiro Nagai (Clinical Therapeutic Trial Center, Ehime University Hospital)
December 5 (Fri) 15:40～17:40 Room 5　Conference room 6, 3F, Himegin Hall
S24 Understanding of tissue specific and comprehensive basic function of drug transporters and its application to the clinical situations
Chair： Ichiro Ieiri (Department of Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University)
  Hiroaki Araki (Division of Pharmacy, Ehime University Hospital)
December 5 (Fri) 15:40～17:40 Room 6　Conference room 8, 3F, Himegin Hall
S25 Clinical Pharmacology at the Bedside I
Chair： Tsuyoshi Shiga (Department of Cardiology, Tokyo Women's Medical University)
  Noriko Nishikawa (Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine)
December 5 (Fri) 15:40～17:40 Room 7　Conference room 11, 1F, Himegin Hall Annex
S26 Drowing a Self-portrait of JSCPT for tomorrow
Chair： Hirotoshi Echizen (Meiji Pharm Univ, Dept Pharmacother)
  Junichi Hasegawa (Division of Pharmacotherapeutics, Faculty of Medicine, Tottori University)
December 6 (Sat) 9:00～11:00 Room 1　Main Hall, 1F, Himegin Hall
S27 Clinical Pharmacology of Oncology Drugs
Chair： Yusuke Tanigawara (Department of Clinical Pharmacokinetics and Pharmaodynamics, School of Medicine, Keio University)
  Yasutsuna Sasaki (Division of Medical Oncology, Department of Medicine, Showa University)
December 6 (Sat) 9:00～11:00 Room 2　Sub Hall, 1F, Himegin Hall
S28 Pharmacokinetic Study on Patients
Chair： Masahiro Nagai (Clinical Therapeutic Trial Center, Ehime University Hospital )
  Yukiko Maruyama (Japan Medical Association Center for Clinical Trials Clinical Research Division )
December 6 (Sat) 9:00～11:00 Room 3　Shinju A, 2F, Himegin Hall
S29 Academic research organization-based drug development and its future perspective
Chair： Tsutomu Yamazaki (Clinical Research Support Center, The University of Tokyo Hospital)
  Hiroshi Watanabe (Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine)
December 6 (Sat) 9:00～11:00 Room 4　Shinju B, 2F, Himegin Hall
S30 Toward consensus building on causality assessment of adverse events
Chair： Kazuhiro　Harada (Kasaoka Daiichi Hospital)
  Osamu Komiyama (Japan Pharmaceutical Manufacturers Association/ Pfizer Japan Inc.)
December 6 (Sat) 9:00～11:00 Room 5　Conference room 6, 3F, Himegin Hall
S31 Efficacy and safety of health foods on the aspect of evaluating biological kinetics and dynamics
Chair： Hiroshi Yamada (School of Pharmaceutical Sciences, University of Shizuoka)
  Noriko Nishikawa (Department of Neurology and Clinical pharmacology, Ehime University Graduate School of Medicine)
December 6 (Sat) 9:00～11:00 Room 6　Conference room 8, 3F, Himegin Hall
S32 Current situation and foresight of investigator-initiated clinical research
Chair： Haruko Yamamoto (Dept. of Advanced Medical Technology Development, National Cerebral and Cardiovascular Center)
  Koji Iwasaki (Global Medical Affairs Japan Dept., Pharmaceutical Development Div., Takeda Pharmaceutical Company Ltd.)
December 6 (Sat) 14:30～16:30 Room 1　Main Hall, 1F, Himegin Hall
S33 Collaboration Between Pharmaceutical Companies and Medical Institutions for Risk Management Plan
Chair： Hiroyuki Furukawa (Clinical Research Center, Yamaguchi Univercity Hospital)
  Kimihiko Tanizawa (Clinical Planning Department, Daiichi Sankyo Co.,Ltd.)
December 6 (Sat) 14:30～16:30 Room 2　Sub Hall, 1F, Himegin Hall
S34 A New Standard of Education Program for CRC Training Focusing on the Support to Global, High-qualiry Clinical Research
Chair： Hideo Kusuoka (Osaka National Hospital)
  Hiroshi Yamada (School of Pharmaceutical Sciences, University of Shizuoka)
December 6 (Sat) 14:30～16:30 Room 3　Shinju A, 2F, Himegin Hall
S35 Clinical pharmacology and health techonology assessment (HTA)
Chair： Kiichiro Tsutani (Dept of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo)
  Junichi Kawakami (Hamamatsu University School of Medicine)
December 6 (Sat) 14:30～16:30 Room 4　Shinju B, 2F, Himegin Hall
S36 Banking of human clinical samples and their usage in the drug development
Chair： Toshio Kumai (St Marianna University School of Medicine)
  Yoshiro Saito (National Institute of Health Sciences)
December 6 (Sat) 14:30～16:30 Room 5　Conference room 6, 3F, Himegin Hall
S37 Sarcopenia and clinical pharmacology
Chair： Yuichi Ando (Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital)
  Kazuo Matsubara (Department of Clinical Pharmacoloty and Therapeutics, Kyoto University Hospital)
December 6 (Sat) 14:30～16:30 Room 6　Conference room 8, 3F, Himegin Hall
S38 Clinical Pharmacology at the Bedside Ⅱ
Chair： Shinichiro Ueda (Department of pharmacology, Graduate School of Medicine, University of the Ryukyus)
  Kazuhiro Harada (Kasaoka　Daiichi　Hospital)
Copyright © 2013 The 35th annual Meeting of The Japanese Society of Clinical Phaqrmacology and Therapeutics All Rights Reserved.