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Overview

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Among the major issues in recent new medicine development, problems such as species differences when extrapolating non-clinical study results to humans and the differences between clinical trial subjects and actual patients when we apply clinical trial results to patients in clinical practice, stand out as challenges which must be overcome in regulatory science research which aims for the proper utilization of medicines considering each patient’s individual risks.


Recent technological progresses in the medicine and pharmacology are expected to provide powerful tools to overcome these barriers, and a longawaited platform that enables patient-engaged new medicine development is gradually being developed. For example, the human genetic code can be analyzed rapidly and at low cost due to the progress of genetic engineering, and searches of disease specific genes in patients’ clinical samples have accelerated. The discovery of iPS cells made it possible to study diseases by direct use of patient cells as well as to enhance new medicine development through screening for efficacy and safety in ways that were previously impossible. Simulation techniques for physiologic and disease conditions have enabled better prediction, which was not possible in prior non-clinical and clinical trials. Moreover, there is the potential for gaining further information which can be applied to individual patients by pharmacoepidemiological research using the enormous quantity of data generated by clinical practice.


This year, Dr. Tatsuo Kurokawa will become the first Japanese President of  DIA. In this memorable year, we would like to provide a forum where academia, government and industry gather to discuss new scientific technologies which will provide breakthroughs for future regulatory science research at the DIA Japan Annual Meeting. It goes without saying that quality, efficacy and safety of medical products are supported by all stakeholders’ ethics and compliance. While the number of stakeholders is increasing due to the large scale of global medicine development, and the wide variety of people who are involved with these new technologies, we would like this meeting to be an opportunity to deeply consider our highest priority objective; ‘for patients’.

Program Committee

  • Yoshinobu  Hirayama, PhD
    Yoshinobu Hirayama, PhD Professor, College of Pharmaceutical Sciences
    Ritsumeikan University, Japan
  • Atsushi  Tsukamoto, PhD
    Atsushi Tsukamoto, PhD Vice President, New Drug Regulatory Affairs
    Daiichi Sankyo Co., Ltd., Japan
  • Hiroyuki  Aono
    Hiroyuki Aono Vice President, Head of Research & Development Solutions Center of Excellence
    IQVIA Services Japan K.K., Japan
  • Yoshikata  Furuya, MSc
    Yoshikata Furuya, MSc Director, Vaccine Policy, Health Policy
    MSD K.K., Japan
  • Kanji  Hirai, RPh
    Kanji Hirai, RPh Director, Regulatory Policy & Intelligence, Regulatory Affair Area, Japan Dvlpmt
    MSD K.K., Japan
  • Akihiro  Hirakawa, PhD
    Akihiro Hirakawa, PhD Project Associate Professor, Department of Biostatistics and Bioinformatics
    Graduate School of Medicine, The University of Tokyo, Japan
  • Shinzo  Hiroi, PhD, MPH, RPh, PMP
    Shinzo Hiroi, PhD, MPH, RPh, PMP Head of Global Medical Affairs
    Shionogi & Co., Ltd., Japan
  • Chieko  Hirose, MSc
    Chieko Hirose, MSc Regulatory Coordination Officer
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Keiichi  Inaizumi, MSc
    Keiichi Inaizumi, MSc Manager, Clinical Operations and Compliance 1, Development Operations
    Pfizer Japan Inc., Japan
  • Makiko  Isozaki
    Makiko Isozaki
    Japan Agency for Medical Research and Development (AMED), Japan
  • Tatsuhiro  Kanoo, MPharm, RPh
    Tatsuhiro Kanoo, MPharm, RPh Associate Director, Corporate Communication
    Takeda Pharmaceutical Company Limited, Japan
  • Kengo  Kawasaki
    Kengo Kawasaki Senior Director, Data Management Group, Japan-Asia Data Science, Development
    Astellas Pharma Inc., Japan
  • Kana  Maruyama
    Kana Maruyama Manager, Labeling Group, Regulatory Compliance Department, RA Division
    Janssen Pharmaceutical K.K., Japan
  • Yoshihiro  Matsuda, PhD
    Yoshihiro Matsuda, PhD Senior Scientist (for Quality), Pharmacist
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Yukihiro  Matsuda, MSc
    Yukihiro Matsuda, MSc Research Scientist, Trial Mgmt., Clinical Development Operations & Innovatiion
    Eli Lilly Japan K.K., Japan
  • Ken  Nakajima, RPh
    Ken Nakajima, RPh Head of Medical Safety, Pharmacovigilance Department
    Otsuka Pharmaceutical Co., Ltd., Japan
  • Yasutsugu  Nakano
    Yasutsugu Nakano Sr. Director, Head of Development Regulatory Affairs 2, Regulatory Affairs Dept.
    Shionogi & Co., Ltd., Japan
  • Goshi  Ozawa, MS
    Goshi Ozawa, MS President
    Real Discovery Outdoors Co.,Ltd., Japan
  • Satoshi  Saeki, MSc
    Satoshi Saeki, MSc Associate Director, Business Process Improvement & Innovation, QuILS
    Astellas Pharma Global Development, Inc., United States
  • Takashi  Sato, MSc, PMP
    Takashi Sato, MSc, PMP R&D Planning Department
    Kyowa Hakko Kirin Co., Ltd., Japan
  • Machiko  Sumi
    Machiko Sumi Regulatory Affairs 1, Global Regulatory Affairs Dept, Corporate Quality Mgmt Div
    Shionogi & Co., Ltd., Japan
  • Keiko  Tsumori
    Keiko Tsumori Associate Director, Medical Writing, Regulatory Affairs Area, Japan Development
    MSD K.K., Japan
  • Hisashi  Urushihara, DrPH
    Hisashi Urushihara, DrPH Professor, Div. of Drug Development and Regulatory Science, Faculty of Pharmacy
    Keio University, Japan
  • Yasunori  Yoshida
    Yasunori Yoshida Food Safety Commission of Japan
    Cabinet Office, Government of Japan, Japan
  • Junichi  Nishino, MSc, RPh
    Junichi Nishino, MSc, RPh Head, RA Functions Department, Regulatory Office Japan
    Novartis Pharma K.K., Japan
  • Junko  Sato, PhD
    Junko Sato, PhD Director, Office of International Programs
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313
Japan@DIAglobal.org
www.diajapan.org

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