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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)
Deborah Driscoll, MS
Vice President, MRL Quality Assurance, Merck & Co., Inc., United States
Quality by Design (QbD) Principles and Practical Application
Kotone Matsuyama, RPH
Center for Clinical Research and Development, National Center for Child Health and Development, Japan
Protocol Planning Using Quality by Design (QbD) Approach
Haruko Kuzuyama, RPH
Study Coordinator, Clinical Research Support Center, The University of Tokyo Hospital, Japan
Improving Document Management Process of Clinical Trial Source Data Using Six Sigma
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