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[V2-S5] Think "Quality" of Clinical Trial - Quality by Design for Improvement of Quality Management Method
Session Chair(s)
Osamu Komiyama
Senior Manager, Statistical Research & Data Science
Pfizer R&D Japan G.K., Japan
It’s widely known that the quality of clinical trials is generally determined during the phase of planning. However, the planning phase still has many issues that can be resolved and improved. The Quality by Design (QbD) proposed by CTTI is a method that can help resolve and improve such issues. This session will show how to implement better quality management in order to achieve QbD and present ways to help with the clinical trial planning phase, which in turn will improve the quality of the clinical trials themselves.
Speaker(s)
Quality by Design (QbD) Principles and Practical Application
Deborah Driscoll, MS
Merck & Co., Inc., United States
Vice President, MRL Quality Assurance
Protocol Planning Using Quality by Design (QbD) Approach
Kotone Matsuyama, RPH
National Center for Child Health and Development, Japan
Center for Clinical Research and Development
Improving Document Management Process of Clinical Trial Source Data Using Six Sigma
Haruko Kuzuyama, RPH
The University of Tokyo Hospital, Japan
Study Coordinator, Clinical Research Support Center