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Final Program is now available! Please click here.

Online Registration has been closed. Onsite Registration will be available at Tokyo Big Sight.

Today we stand on the threshold of the Age of Big Data and Artificial Intelligence (AI); soon we can expect world-class medical databases to enable dramatic advances in drug safety and in research and development. The structural reforms mandated by Abenomics (the economic policies championed by the current Japanese Prime Minister Abe) are pushing government and industry to develop strategic policies in information and communications technology (ICT) that will promote innovation in areas such as medical treatment. Meanwhile, the popular media report novel treatment options for patients through genetic analysis, and new horizons for regenerative medicine technology. All of this has raised expectations for further developments in medical treatment.

Last year's topic was "Breakthrough in Regulatory Science for Patient-Engaged Medical Treatment." This year we continue our focus on advances in patient-centric drug development, with special emphasis on how AI and Big Data, particularly therapeutic and genomic information, will affect the development of next-generation medicines.  Our 2017 keynote speakers, Professor Tomohiro Sawa of Teikyo University, and 2016 Nobel laureate in Physiology or Medicine Professor Yoshinori Ohsumi of Tokyo Institute of Technology, are uniquely qualified to address these areas.

Our general sessions will cover a wide range of topics.  Sessions related to AI and Big Data will include the application of digital health options to clinical trials, and the use of disease registries and medical databases throughout the process from drug development to post-marketing safety measures. GPSP is scheduled for revision this year, and discussions are also underway regarding the practical incorporation of medical databases into post-marketing safety measures. We will address new developments in ICH and other regulatory topics, particularly in the context of reforms to enable early access to innovative drug products, and new progress on global harmonization in drug development. In addition, the Summit of Heads of Medicines Regulatory Agencies is scheduled for October of this year, so we expect to offer some "hot topic" reports.

Building on the theme of last year's conference, industry, government, and academia will discuss ways to encourage drug development including from the patient's perspective. We will also examine guidelines to optimize the use of novel medical products. Other presentations will cover development strategies for drugs for cancer and rare diseases, products for regenerative medicine, and biosimilars. Discussions will include risk management plans, labeling, risk communication, medical affairs, and health technology assessment. Additional topics will include quality management, clinical study operations, and medical devices. By emphasizing cooperation between industry, government, and academia, highlighting important developments in academic research, and offering a wide range of educational sessions, we hope to provide a broad perspective on the changes that are coming, and to offer an international  platform  for discussion of the issues and expectations that are associated with those changes.

We hope that the discussions at this year's DIA Japan conference will lead to valuable new medical developments that will truly respond to the needs and hopes of patients. We look forward to seeing you at Tokyo Big Site in November.


Program Committee

  • Yasuhiro  Fujiwara, MD, PhD
    Yasuhiro Fujiwara, MD, PhD Chief Executive
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Akiko  Ikeda, RPh
    Akiko Ikeda, RPh Associate Director, Regulatory Development Dept.
    Janssen Pharmaceutical K.K., Japan
  • Yoshikata  Furuya, MSc
    Yoshikata Furuya, MSc Manager, General Affairs Division
    Sankeien Hoshoukai Foundation, Japan
  • Natsuko  Hamada
    Natsuko Hamada Senior Regulatory Scientist, Therapeutic Area Regulatory,
    Eli Lilly Japan K.K., Japan
  • Mitsuo  Hayashi, MSc, RPh
    Mitsuo Hayashi, MSc, RPh Director & Head, Clinical Enablement
    MSD K.K., Japan
  • Akihiro  Hirakawa, PhD
    Akihiro Hirakawa, PhD Professor,Graduate School of Medical and Dental Sciences
    Tokyo Medical and Dental University, Japan
  • Ayaka  Hiramatsu, MPharm
    Ayaka Hiramatsu, MPharm Reviewer, Office of New Drug II
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Kanji  Hirai, RPh
    Kanji Hirai, RPh Director, Regulatory Policy & Intelligence, Regulatory Affair Area, Japan Dvlpmt
    MSD, Japan
  • Shinzo  Hiroi, PhD, MPH, RPh, PMP
    Shinzo Hiroi, PhD, MPH, RPh, PMP Head of Global Medical Affairs
    Shionogi & Co., Ltd., Japan
  • Takahiro  Inoue
    Takahiro Inoue Director, Division of Drug Research Promotion
    Japan Agency for Medical Research and Development (AMED), Japan
  • Kazuhiko  Ishida, MSc, RPh
    Kazuhiko Ishida, MSc, RPh Director, Pharmacovigilance
    Astellas Pharma Inc., Japan
  • Koji  Iwasaki, PhD
    Koji Iwasaki, PhD Professor, Academic Clinical Research Center,
    Osaka University Hospital, Japan
  • Masashi  Kaichi
    Masashi Kaichi
    Japan Agency for Medical Research and Development (AMED), Japan
  • Kazuhiro  Kanmuri, PhD
    Kazuhiro Kanmuri, PhD Vice President, Product Development and Clinical Operations
    Ascent Development Services Inc, Japan
  • Chika  Kiryu, DVM, PhD
    Chika Kiryu, DVM, PhD Manager
    Janssen Pharmaceutical K.K., Japan
  • Nobuhiro  Koga, MBA, PMP
    Nobuhiro Koga, MBA, PMP Director, Clinical Operation
    Nihon Servier Co., Ltd., Japan
  • Yoshiko  Komuro, PhD
    Yoshiko Komuro, PhD Inspection Director in Office of Non-clinical and Clinical Compliance
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Kaori  Muto, PhD
    Kaori Muto, PhD Professor, Department of Public Policy, The Institute of Medical Science
    The University of Tokyo, Japan
  • Goshi  Ozawa, MS
    Goshi Ozawa, MS CEO & President
    Real Discovery Outdoors Co,. Ltd., Japan
  • Rie  Matsui, RPh
    Rie Matsui, RPh Senior Director, Regional Labeling Head for APAC
    Pfizer R&D Japan, Japan
  • Takashi  Sato, MSc, PMP
    Takashi Sato, MSc, PMP
    PM Orchestra Takashi Sato, Japan
  • Yumi  Sugiura, MRCP
    Yumi Sugiura, MRCP Global Clinical Operations, Global Data Management and Centralized Monitoring
    Bristol-Myers Squibb K.K., Japan
  • Atsushi  Tsukamoto, PhD, MSc
    Atsushi Tsukamoto, PhD, MSc Vice President, New Drug Regulatory Affairs Department
    Daiichi Sankyo Company, Limited, Japan
  • Keiko  Tsumori, MSc
    Keiko Tsumori, MSc Associate Director, Medical Writing, Regulatory Affairs Area, Japan Development
    MSD K.K., Japan
  • Hisashi  Urushihara, DrPH
    Hisashi Urushihara, DrPH Professor, Faculty of Pharmacy
    Keio University, Japan
  • Satomi  Yagi
    Satomi Yagi Reviewer, Office of New Drug IV
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Koichiro  Yuji, MD, PhD, FACP
    Koichiro Yuji, MD, PhD, FACP Project Associate Professor, The Institute of Medical Science
  • Junichi  Nishino, MSc, RPh
    Junichi Nishino, MSc, RPh Head, Regulatory Affairs Department
    Otsuka Pharmaceutical Co., Ltd., Japan
  • Yoshihiko  Ono, RPh
    Yoshihiko Ono, RPh Head of Regulatry Affairs
    MSD Japan, 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