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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)
Building Quality in Academic Clinical Trials - Challenges to Overcome -
Takuhiro Yamaguchi, PhD
Tohoku University Graduate School of Medicine, Japan
Professor, Biostatistics
Key Concepts of TransCelerate RBM Methodology
Satoshi Saeki, MSc
Astellas Pharma Inc., Japan
Head of Japan Operational Excellence, Medical Affairs, Japan
Protocol Development Process Using Quality by Design Method
Kotone Matsuyama, RPh
Nippon Medical School, Japan
Professor, Department of Health Policy and Management
Clinical Trial Act and Quality Control and Assurance
Masakatsu Imoto
Pharmaceuticals and Medical Devices Agency (PMDA), Japan