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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)
QMS in ICH E6 (R2)
Tsukasa Ikeda
AstraZeneca K.K., Japan
Director, Quality Assuarance Asia Pac, Science Unit
Implement Quality by Design in Clinical Studies ~ for a Practical Application of Quality Tools ~
Hirotaka Inoue, PhD, MBA
GlaxoSmithKline K.K., Japan
Head, Leading Changes Office, Japan Development & Medical Affairs Division
Quality by Design from the View of Clinical Operation
Tatsuya Koishi, PhD
EPS Corporation, Japan
Deputy General Manager, Clinical Development Department3
Quality by Design from the Viewpoint of Reliability
Makoto Hirose, MSc
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office Director, Office of Non-clinical and Clinical Compliance