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14th DIA Japan Annual Meeting 2017

[V5-S6] Quality Management and Lean Six Sigma in Clinical Trials in ARO and Pharmaceutical Companies

    Session Chair(s)
      Toshihiko  Watanabe

      Toshihiko Watanabe

      • Advisor
      • Japan CRO Association, Japan
    To manage qualities in clinical research and clinical studies, introduction of Quality by Design (QbD), Risk Based Approach and Critical to Quality (CTQ) was expected based on enactment of Clinical Study Law and GCP renovation. However, no tangible example was reported as of today and field level ingenuity with limited resources is being applied to clinical trials. In this session, Lean Six Sigma (LSS) Outline, QbD example and improvement example of quality in clinical studies at pharmaceutical industry and ARO by LSS method, that is ISO certified quantitative process improvement and worldwide efficient quality management tool, will be presented.
      Hirotaka  Inoue, PhD, MBA

      Lean Six Sigma, an International Standard for Quality Management

      Hirotaka Inoue, PhD, MBA

      • Head, Leading Changes Office, Japan Development & Medical Affairs Division
      • GlaxoSmithKline K.K., Japan
      Souta  Mizumoto, MPharm

      Case Introduction – How Lilly Japan Leverage Lean Six Sigma Methodology

      Souta Mizumoto, MPharm

      • Director & Six Sigma Champion, Global Patient Safety, Medicines Development Unit
      • Eli Lilly Japan K.K., Japan
      Yuko  Kageyama, MT

      A Practical Example of Applying Lean Six Sigma Method at the Academic Clinical Research Site

      Yuko Kageyama, MT

      • Clinical Research Support Center P1 Unit, Department of Clinical Laboratory
      • The University of Tokyo Hospital, Japan

Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313