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[V5-S6] Quality Management and Lean Six Sigma in Clinical Trials in ARO and Pharmaceutical Companies
Session Chair(s)
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.
Speaker(s)
Hirotaka Inoue, PHD, MBA
Head, Leading Changes Office, Enterprise Transformation, GlaxoSmithKline K.K., Japan
Lean Six Sigma, an International Standard for Quality Management
Souta Mizumoto, MPHARM, MSC
Director, Global Patient Safety-Japan; Six Sigma Champion, Eli Lilly Japan K.K., Japan
Case Introduction – How Lilly Japan Leverage Lean Six Sigma Methodology
Yuko Kageyama, MT
Research and Development Policy Division, Ministry of Health, Labour and Welfare Government of Japan, Japan
A Practical Example of Applying Lean Six Sigma Method at the Academic Clinical Research Site
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