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Overview

SUBMIT YOUR ABSTRACT

DIA invites you to submit a presentation abstract for the 21st Annual Workshop for Clinical Data Management, to be held in Tokyo on February 19-20, 2018.

Calling Abstracts:

We are calling for abstracts that show a practical example and/or case-study of the following fields:

  • Risk Based Monitoring (RBM) implementation or case-study: Implementation experience of RBM, effects, and challenges based on experience
  • Real-World Data (RWD) implementation or case study: Examples of database research, registry data management, and data usage
  • Investigator-Led Clinical Trial implementation or case study: Implementation experience of RBM, effects, and challenges based on experience
  • eSource implementation or case study: Implementation experience of ECOA, Smart Trial, Electronic Health Record Integration, or mHealth Trials
  • Education: Examples of efforts related to DM education
  • Submission Deadline: September 8, 2017 (Japan time)

    Notification: by September 29, 2017

    All abstracts have to be submitted online at DIAglobal.org/Abstracts

    Please read additional information on the Abstracts Details.

    Questions? Contact Japan@DIAglobal.org


    PROGRAM OVERVIEW

    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 Senior Manager, Japan Clinical Informatics & Innovation Development Operations
      Pfizer Japan Inc., Japan
    • Yukikazu  Hayashi
      Yukikazu Hayashi Division Manager, Data Science Divisioin II
      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 Clinical Data Manager, Clinical Research Support Center
      The University of Tokyo Hospital, Japan
    • Yukiko  Nagata
      Yukiko Nagata Associate Director, Clinical Data Management & Technology
      Takeda-PRA Development Center KK, Japan
    • Hitoshi  Ozawa
      Hitoshi Ozawa 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
      Daiichi Sankyo Co., Ltd., Japan
    • Yumi  Sugiura, MRCP
      Yumi Sugiura, MRCP Central Monitor, Global Data Strategies and Solutions
      Bristol-Myers Squibb K.K., 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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