ユーザーIDをお忘れですか? or パスワードをお忘れですか?

東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V1-S4] How Can We Define and Manage Quality Goals for Clinical Trials Using a Quality Tolerance Limit (QTL) Approach?

Session Chair(s)

Satoshi  Saeki, MSc

Satoshi Saeki, MSc

Head of Japan Operational Excellence, Medical Affairs, Japan

Astellas Pharma Inc., Japan

In the 1920s, Walter Shewhart pioneered statistical approaches for setting control/tolerance limits in manufacturing, and his protégé W. Edwards Deming built on this work to establish the renowned Plan-Do-Study-Act “Deming Wheel” as a comprehensive quality management framework. These concepts in quality management are about to be applied in clinical trials as Quality Tolerance Limits (QTLs). ICH E6 (R2) clearly defines QTLs as a measure for identifying systematic issues that can impact subject safety or reliability of trial results, thus QTLs can be considered quality goals for these clinical studies. Last year provided conceptual discussions around QTLs. This year a more practical discussion will be presented that focuses on actual approaches in real-world situations, e.g., identification of QTL parameters, setting tolerance limits, and QTL monitoring using a mock protocol synopsis. Existing tools from risk-based monitoring will be highlighted for their use in developing and managing QTLs.


Christopher P Hanna, PhD, PMP

Risk-based Quality Management in Clinical Trials Using Quality Tolerance Limits (QTLs)

Christopher P Hanna, PhD, PMP

Kattner-Thalmann Partners, United States