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[V4-S5] Quality by Design; Strategically Building the Quality of Clinical Study by Academia
Session Chair(s)
Takuhiro Yamaguchi, PHD
Professor, Biostatistics, Tohoku University Graduate School of Medicine, Japan
How to secure critical quality for clinical trials is attracting worldwide attention as a design or management issue and that also introduced into the reflection paper of the E6 guidelines agreed last November and the E8 guidelines issued in January 2017. In this session, we outline the Quality by design and the Risk based approach to secure quality of clinical trials with an exit strategy, and make discussions.
Speaker(s)
Takuhiro Yamaguchi, PHD
Professor, Biostatistics, Tohoku University Graduate School of Medicine, Japan
Building Quality in Academic Clinical Trials - Challenges to Overcome -
Satoshi Saeki, MSC
Head of Japan Operational Excellence, Medical Affairs, Japan, Astellas Pharma Inc., Japan
Key Concepts of TransCelerate RBM Methodology
Kotone Matsuyama, RPH
Center for Clinical Research and Development, National Center for Child Health and Development, Japan
Protocol Development Process Using Quality by Design Method
Masakatsu Imoto
, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Clinical Trial Act and Quality Control and Assurance