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[V6-S6] Rethinking Quality in Clinical Trials - What are Quality Tolerance Limits (QTLs) and How Should they be Adapted in Clinical Studies to Fulfill New ICH-E6 Requirement?
Session Chair(s)
Satoshi Saeki, MSc
Head of Japan Operational Excellence, Medical Affairs, Japan
Astellas Pharma Inc., Japan
Speaker(s)
Quality Tolerance Limits – A history and the Why, How, What and Where of Implementation in Clinical Trials
William Andrew Lawton
Risk Based Approach Ltd, United Kingdom
Director / Consultant
Hiromichi Isaka, MPharm
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Non-clinical and Clinical Compliance
Yumi Sugiura, MRCP
Bristol-Myers Squibb K.K., Japan
Global Clinical Operations, Global Data Management and Centralized Monitoring