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Tower Hall Funabori

Feb 27, 2023 9:00 AM - Apr 15, 2023 12:30 PM

4-1-1 Funabori, Edogawa-ku, Tokyo, 134-0091 Japan

26th DIA Japan Annual Workshop for Clinical Data Management


The program is in preparation.

More than a quarter of a century has passed since this workshop was first presented by DIA Japan, and as we convene for the 26th time, we are about to step into a new stage together. Since that first workshop, the clinical development environment has undergone rapid changes, and each time various methodologies and tools are developed, Clinical Data Manager (CDMs) have responded flexibly, proposing and disseminating changes for new data collection and management strategies and practices: For example, changing from paper to electronic data capture, developing more complex study designs, implementing risk-based monitoring, and more. In line with these trends, regulatory authorities have also issued and revised laws and guidelines, particularly in ICH-E6 and ICH-E8. International cooperation is also becoming more important in these areas. The COVID-19 pandemic further forced us to change our operations. While uncertainty about various changes that are constantly occurring remains, the CDM often acts as a hub for collaboration with other roles and stakeholders involved in the clinical development environment and responds by formulating the best action at the best time. In this way, CDMs have continued to adopt a wide variety of major changes that affect the methodology of clinical trials and clinical research, plus small changes and adjustments in their daily operations. Such adaptability may be one of the most important skills required for CDM. It is no exaggeration to say that CDMs manage not only clinical data but all related processes.

Recently, discussions on patient-focused drug development, secondary use of data, real-world data/evidence, etc. have become more active, and changes in the growing diversification of data sources, advances in technology, and the spread of de-centralized clinical trials (DCTs) are accelerating. This workshop will providing a place where we can mitigate concerns about such changes and share new expectations by introducing the latest data-related use cases, information from regulatory authorities, and related eff orts to address these changes. Our common purpose of protecting subjects and ensuring science and reliability through the “data,” may be the reason why such meaningful sharing and discussion are possible.

While inheriting the significance that has been cherished over the past quarter century, this 2023 workshop will firmly grasp the new wave of change, address new uncertainties and expectations, and take a strong new step forward through deep and lively discussions, that introduce new technologies with case studies, and respectfully considers opinions from industry, government, academia, and other perspectives. 


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


For those who would like to register in the Day3 Special Event

Session will be conducted in Japanese language only. Please apply from the dedicated site.

?Those who have registered for 26th Annual Workshop in Japan for Clinical Data Management can participate for free.


Want to learn more about 26th DIA Japan Annual Workshop for Clinical Data Management? You've come to the right site!


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

  • Misato  Kuwagaki, MS
    Misato Kuwagaki, MS Associate Director, Data Sciences
    Eli Lilly Japan K.K., Japan
  • Yukikazu  Hayashi
    Yukikazu Hayashi Assistant Head of Clinical Development
    A2 Healthcare Corporation, Japan
  • Yumiko  Asami
    Yumiko Asami Chapter Head of Clinical Data Science
    Boehringer Ingelheim, Japan
  • Michiko  Ishida
    Michiko Ishida Office of Non-clinicaland Clinical Compliance
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Kazumi  Itayama
    Kazumi Itayama Data Monitoring & Management
    Pfizer R&D Japan, Japan
  • Yuu  Jincho, JD, MSc
    Yuu Jincho, JD, MSc Manager, Data Practice Group, Biomedical Data Sciences Dept., RD Japan
    GlaxoSmithKline K.K., Japan
  • Juri  Kato
    Juri Kato Data manager
  • Yasuhiro  Matsumoto
    Yasuhiro Matsumoto Manager, Data Management Group, Data Science, Development
    Astellas Pharma Inc., 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
  • Nanako  Hamazaki
    Nanako Hamazaki Tsukuba Clinical Research & Development Organization
    University of Tsukuba, Japan
  • Tetsuya  Sasaki, PhD
    Tetsuya Sasaki, PhD Department of International Clinical Development
    National Cancer Center Hospital, Japan
  • Eri  Sekine
    Eri Sekine Executive Vice President
    CMIC Group, Japan
  • Yoko  Hattori
    Yoko Hattori Project Assistant Professor
    Chiba University Hospital Clinical Research Center, Japan
  • Akiko  Kumagai
    Akiko Kumagai Associate Manager
  • Mika  Ogasawara
    Mika Ogasawara Data Quality Lead, Biometrics and Data Management
    Pfizer R&D Japan G.K., Japan

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