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Advanced technology such as artificial intelligence, robotics, and natural language processing is penetrating and spreading healthcare product development, while use of eSource and digital devices supports digital data flow and suggests a new clinical trial methodology. Standardization to CDISC is envisioned by 2020 upon full implementation of eData submission, and, combined with the Common Protocol Template proposal, is also helping to lead the standardization and digitalization of end-to-end data flow.

Investigator-initiated trials and collaboration between academia and industry continue to increase as advanced and translational medical technologies such as regenerative and genetic medicine are more deeply incorporated into medical practice in Japan. The impact of these advanced technologies on approaches to drug and device development remains undetermined.

Are clinical data managers (CDMs) ready to ensure the quality of their data through Quality by Design (QbD) as ICH E6(R2) and E8 are being implemented and the “GCP Revolution” is openly discussed? What actions must CDMs take to extend the Risk-Based Approach from clinical trial design to clinical trial reporting and beyond, to post-market safety monitoring? Our overall theme Clinical Data Management in New Era: Enhance Data Reliability and Utilization to Adapt to Renovation reflects the fact the range of clinical trial types and data sources are rapidly expanding. We will collaboratively discuss how CDMs can enhance data reliability and utilization for various clinical trial designs and data sources throughout the drug and/or device product lifecycle, including post-market monitoring. It aims to improve the quality of both clinical research and clinical data management in Japan, and will provide numerous opportunities for networking and information exchange among industry, government, and academia.

Who should attend?

  • Clinical data managers
  • Clinical research coordinators
  • Biostatisticians
  • Clinical development professionals
  • Information technology professionals
  • QC/QA professionals
  • Regulatory affairs professionals
  • Postmarketing surveillance professionals

Program Committee

  • Motohide  Nishi, MBA
    Motohide Nishi, MBA Vice President, Asia Pacific Technology
    Medidata Solutions K.K., Japan
  • Mika  Ogasawara
    Mika Ogasawara Manager, Japan Clinical Informatics & Innovation, Biometrics and Data Management
    Pfizer Japan Inc., Japan
  • Yukikazu  Hayashi
    Yukikazu Hayashi Division Manager, Development Strategy Division
    A2 Healthcare Corporation, Japan
  • Akimitsu  Ikeura, MSc
    Akimitsu Ikeura, MSc Manager, Data Management Group, Biostatistics & Data Management Dept.
    Daiichi Sankyo Co., Ltd., Japan
  • Misato  Kuwagaki, MS
    Misato Kuwagaki, MS Clinical Development Organization – Clinical Information & Process Automation
    Eli Lilly Japan K.K., Japan
  • Kyoko  Minamoto
    Kyoko Minamoto Practical Research for Innovative Cancer Control Management Office (PRIMO)
    National Cancer Center, Japan
  • Tempei  Miyaji, MSc
    Tempei Miyaji, MSc Project Assistant Professor, Department of Clinical Trial Data Management
    The University of Tokyo Hosptial, Japan
  • Yukiko  Nagata
    Yukiko Nagata Associate Director, Clinical Data Management & Technology
    Takeda PRA Development Center KK, Japan
  • Hitoshi  Ozawa, MPharm
    Hitoshi Ozawa, MPharm GCP Inspector, Office of Non-Clininical and Clinical Compliance
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Yasuharu  Shibata
    Yasuharu Shibata Associate Director, Head of Clinical Data Mgt., Clinical Operations Area
    MSD K.K., Japan
  • Yumiko  Asami
    Yumiko Asami Statistician, Manager, Electronic Data System Management Group, Biostatistics &
    Daiichi Sankyo Co., Ltd., Japan
  • Yumi  Sugiura, MRCP
    Yumi Sugiura, MRCP Global Clinical Operations, Global Data Management and Centralized Monitoring
    Bristol-Myers Squibb, Japan
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