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14th DIA Japan Annual Meeting 2017


[V4-S5] Quality by Design; Strategically Building the Quality of Clinical Study by Academia

    Session Chair(s)
      Takuhiro  Yamaguchi, PhD

      Takuhiro Yamaguchi, PhD

      • Professor, Biostatistics
      • Tohoku University Graduate School of Medicine, Japan
    How to secure critical quality for clinical trials is attracting worldwide attention as a design or management issue and that also introduced into the reflection paper of the E6 guidelines agreed last November and the E8 guidelines issued in January 2017. In this session, we outline the Quality by design and the Risk based approach to secure quality of clinical trials with an exit strategy, and make discussions.
    Speaker(s)
      Takuhiro  Yamaguchi, PhD

      Building Quality in Academic Clinical Trials - Challenges to Overcome -

      Takuhiro Yamaguchi, PhD

      • Professor, Biostatistics
      • Tohoku University Graduate School of Medicine, Japan
      Satoshi  Saeki, MSc

      Key Concepts of TransCelerate RBM Methodology

      Satoshi Saeki, MSc

      • Associate Director, Business Process Improvement & Innovation, QuILS
      • Astellas Pharma Global Development, Inc., United States
      Kotone  Matsuyama, RPh

      Protocol Development Process Using Quality by Design Method

      Kotone Matsuyama, RPh

      • Professor, Dept of Health Policy and Mgmt, Ctr for Strategic Research Initiative
      • Nippon Medical School, Japan
      Masakatsu  Imoto

      Clinical Trial Act and Quality Control and Assurance

      Masakatsu Imoto

      • Director, Research and Development Division, Health Policy Bureau
      • Ministry of Health, Labour and Welfare (MHLW), Japan

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