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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

13th DIA Japan Annual Meeting 2016

[V2-S5] Think "Quality" of Clinical Trial - Quality by Design for Improvement of Quality Management Method

Session Chair(s)

Osamu  Komiyama

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

Quality by Design (QbD) Principles and Practical Application

Deborah Driscoll, MS

Merck & Co., Inc., United States

Vice President, MRL Quality Assurance

Kotone  Matsuyama, RPh

Protocol Planning Using Quality by Design (QbD) Approach

Kotone Matsuyama, RPh

Nippon Medical School, Japan

Professor, Department of Health Policy and Management

Haruko  Kuzuyama, RPh

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

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