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14th DIA Japan Annual Meeting 2017

[V6-S4] Quality by Design; Strategically Building the Quality of Clinical Study by Pharmaceutical Company

    Session Chair(s)
      Koji  Iwasaki, PhD

      Koji Iwasaki, PhD

      • Professor, Academic Clinical Research Center, Department of Medical Innovation
      • Osaka University Hospital, Japan
    Recently, it is necessary to keep the quality of clinical studies that organized by pharmaceutical company. Creating clinical study protocol by the method of “Quality by Design (QbD)” and it’s risk based monitoring (RBM) will be expected with ICH-E6 and ICH-E8 renovation. The pilot study around RBM was progressed, however the method of QbD will discuss deeply. In this session, we will discuss around the strategic manner to create the quality of clinical study by the method of QbD.
      Tsukasa  Ikeda

      QMS in ICH E6 (R2)

      Tsukasa Ikeda

      • Director, Quality Assuarance Asia Pac, Science Unit
      • AstraZeneca K.K., Japan
      Hirotaka  Inoue, PhD, MBA

      Implement Quality by Design in Clinical Studies ~ for a Practical Application of Quality Tools ~

      Hirotaka Inoue, PhD, MBA

      • Head, Leading Changes Office, Japan Development & Medical Affairs Division
      • GlaxoSmithKline K.K., Japan
      Tatsuya  Koishi, PhD

      Quality by Design from the View of Clinical Operation

      Tatsuya Koishi, PhD

      • Deputy General Manager, Clinical Development Department3
      • EPS Corporation, Japan
      Makoto  Hirose, MSc

      Quality by Design from the Viewpoint of Reliability

      Makoto Hirose, MSc

      • Office Director, Office of Non-clinical and Clinical Compliance
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Contact us

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

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