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Asakusabashi Hulic Hall

Feb 19, 2019 9:00 AM - Feb 20, 2019 6:00 PM

Hulic Asakusabashi Building 2F, 1-22-16 Asakusabashi, Taito-ku, Tokyo, 111-0053 Japan

22nd DIA Japan Annual Workshop for Clinical Data Management

Overview

Online registration is closed. Onsite registration will be available. Please come to venue during 12:30-13:00 on Tuesday, February 19 at Asakusabashi Hulic Hall.

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.

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Exhibits

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 Japan Site Leader & VP Professional Services
    Medidata Solutions K.K., Japan
  • Mika  Ogasawara
    Mika Ogasawara Data Quality Lead, Biometrics and Data Management
    Pfizer R&D Japan G.K., Japan
  • Yukiko  Nagata
    Yukiko Nagata Director, Biometrics
    ICON Clinical Research GK, 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, MSc
    Yasuharu Shibata, MSc Head of Clinical Data Management, Cliinical Data Management
    MSD K.K., Japan
  • Keisuke  Utsumi
    Keisuke Utsumi Head, Development Global Medical, Japan Development Division
    GlaxoSmithKline K.K., Japan
  • Yukikazu  Hayashi
    Yukikazu Hayashi Assistant Head of Clinical Development
    A2 Healthcare Corporation, Japan
  • Akimitsu  Ikeura, MSc
    Akimitsu Ikeura, MSc Associate Director, Data Management Group, Biostatistics & Data Management Dept.
    Daiichi Sankyo Co., Ltd., Japan
  • Misato  Kuwagaki, MS
    Misato Kuwagaki, MS Associate Director, Data Sciences
    Eli Lilly Japan K.K., Japan
  • Kyoko  Minamoto
    Kyoko Minamoto Medical Technologist
    National Cancer Center, Japan
  • Tempei  Miyaji, MSc
    Tempei Miyaji, MSc Project Assistant Professor, Department of Clinical Trial Data Management
    The University of Tokyo, Japan
  • Yumi  Sugiura, MRCP
    Yumi Sugiura, MRCP Global Clinical Operations, Global Data Management and Centralized Monitoring
    Bristol-Myers Squibb K.K., Japan
  • Yumiko  Asami
    Yumiko Asami Chapter Head of Clinical Data Science
    Boehringer Ingelheim, Japan

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