×
返回 Agenda
[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)
William Andrew Lawton
Director / Consultant, Risk Based Approach Ltd, United Kingdom
Quality Tolerance Limits – A history and the Why, How, What and Where of Implementation in Clinical Trials
Hiromichi Isaka, MPHARM
Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yumi Sugiura, MRCP
Global Clinical Operations, Global Data Management and Centralized Monitoring, Bristol-Myers Squibb K.K., Japan