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Online Registration has been closed.

Onsite Registration will be available at the venue from 12:00-12:30 on Monday, February 19 and from 8:30-9:00 on Tuesday, February 20, 2018.

Advanced and translational medical technology, such as regenerative medicine and genetic medicine, are already being incorporated into our medical practices, and artificial intelligence and medical robots are developing and spreading. At the same time, the use of eSource data, genomics data, and real-world data is accelerating to provide important health information about patients. Under such circumstances, the Clinical Data Manager (CDM) not only manages the data of conventional clinical trials and clinical research, but is also required to make a change toward the next era. By learning and applying new creative ideas, we will determine the direction the CDM should evolve.

Are CDMs ready to break away from "error-free faith" in securing data quality along with the application of updated ICH E6 and E9? The CDM must take the initiative and appropriate actions to change in order to extend the Risk-Based Approach, which began from clinical monitoring, from clinical trials, and furthermore to the safety monitoring activity after marketing.

The overall theme is “New Paradigm - Better Medical Care and a Healthier World Made Possible by CDM”, reflecting the growth of this workshop and how it continually leads innovation in the field. We will discuss how the CDM can contribute to new change and value creation throughout health care development such as clinical development, postmarketing, medical treatment, disease prevention, and more.

This workshop is aimed at improving the quality of clinical research and clinical data management activities and will provide numerous opportunities for networking and information exchange beyond 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
    Misato Kuwagaki Associate Consultant, Process&Technology, Global Data Delivery, Data Sci.&Sol.
    Eli Lilly Japan K.K., Japan
  • Kyoko  Minamoto
    Kyoko Minamoto Practical Research for Innovative cancer control Management Office (PRIMO)
    National Cancer Center, 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 Senior Central Monitor, Global Data Strategies and Solutions
    Bristol-Myers Squibb K.K., Japan
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