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[V6-S4] Quality by Design; Strategically Building the Quality of Clinical Study by Pharmaceutical Company
Session Chair(s)
Koji Iwasaki, PHD
Professor, Academic Clinical Research Center, , 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.
Speaker(s)
Tsukasa Ikeda
Director, Quality Assuarance Asia Pac, Science Unit, AstraZeneca K.K., Japan
QMS in ICH E6 (R2)
Hirotaka Inoue, PHD, MBA
Head, Leading Changes Office, Enterprise Transformation, GlaxoSmithKline K.K., Japan
Implement Quality by Design in Clinical Studies ~ for a Practical Application of Quality Tools ~
Tatsuya Koishi, PHD
Clinical Development Business Headquarters, EPS Corporation, Japan
Quality by Design from the View of Clinical Operation
Makoto Hirose, MSC
Office Director, Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Quality by Design from the Viewpoint of Reliability