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Mar 02, 2022 3:00 PM - Mar 05, 2022 12:00 AM

(Tokyo Standard Time)

25th Clinical Data Management Workshop


Click Here to View the Program

This workshop, held as the first DIA Japan event, now celebrates its 25th anniversary. Throughout this first quarter century, we actively incorporated the expertise of local and international speakers and patients to address the needs of the current era and the challenges of the future in response to so much rapid change in the clinical development environment. We continue to articulate what skill sets the clinical data manager (CDM) needs and what the CDM should do in our interactions with others in industry, government, and academia. The impact of COVID-19 on clinical sites, and today’s urgent need for flexible decision-making and other innovative methods, has given us a new opportunity to realize the importance of this cross-role, purpose-oriented collaboration and communication.

Innovation continues to accelerate in data management practice: for example, the diversification of data sources (including real-world data [RWD], patient health records [PHRs], etc.), utilization of the advanced digital technologies, digital therapeutics (DTx), and decentralized clinical trials, and increased the importance of clinical data management in academic research and registry utilization. Regulatory innovations and other trends also remain active. The August 2020 Revision of the Ministerial Ordinance on Good Clinical Practice for Medical Products provides a reference guide to ensure smooth clinical trial implementation. The New Ethical Guidelines on Life Science and Medical Research for Human Beings were issued in March 2021 to ensure that patient protection and reliable science remain paramount. PMDA also issued Basic Concepts on Use of Registries in Approval Application, which is expected to promote utilization of RWD acquired under actual medical conditions, in March 2021. The June 2021 ICH Reflection paper Proposed ICH Guideline Work to Advance Patient-Focused Drug Development is driving discussions about implementation around the world.

In this 25th anniversary 2022 workshop, we hope to improve the quality of both CDM and clinical research through shared discussions among industry, government, academia, patients, and related stakeholders on the value and future of clinical development data, with people in need of new treatment as our common goal.


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Who should attend?

Professionals involved in:

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

Program Committee

  • Keisuke  Utsumi
    Keisuke Utsumi Head, Development Global Medical, Japan Development Division
    GlaxoSmithKline K.K., Japan
  • Misato  Kuwagaki, MS
    Misato Kuwagaki, MS Associate Director, Data Sciences
    Eli Lilly Japan K.K., Japan
  • Yumiko  Asami
    Yumiko Asami Chapter Head of Clinical Data Science
    Boehringer Ingelheim, Japan
  • Yukikazu  Hayashi
    Yukikazu Hayashi Assistant Head of Clinical Development
    A2 Healthcare Corporation, Japan
  • Michiko  Ishida
    Michiko Ishida Office of Non-clinicaland Clinical Compliance
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Mika  Maeda
    Mika Maeda Lecturer, Section for Human Research Protections, Kitasato University Hospital
    School of Pharmacy, Kitasato University, Japan
  • Yasuhiro  Matsumoto
    Yasuhiro Matsumoto Manager, Data Management Group, Data Science, Development
    Astellas Pharma Inc., Japan
  • Tempei  Miyaji, MSc
    Tempei Miyaji, MSc Project Assistant Professor, Department of Clinical Trial Data Management
    The University of Tokyo, Japan
  • Kotaro  Sato
    Kotaro Sato Senior Data Team Lead, Clinical Data Management, Data Sciences
    IQVIA Services Japan K.K., Japan
  • Yuko  Yamahara
    Yuko Yamahara Clinical Translational Research Center
    Kobe University Hospital, Japan
  • Mika  Ogasawara
    Mika Ogasawara Data Quality Lead, Biometrics and Data Management
    Pfizer R&D Japan G.K., Japan
  • Yoko  Hattori
    Yoko Hattori Project Assistant Professor
    Chiba University Hospital Clinical Research Center, Japan
  • Kyoko  Minamoto
    Kyoko Minamoto Medical Technologist
    National Cancer Center, Japan

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