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14th DIA Japan Annual Meeting 2017

[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

      Satoshi Saeki, MSc

      • Associate Director, Business Process Improvement & Innovation, QuILS
      • Astellas Pharma Global Development, Inc., United States
      William Andrew Lawton

      Quality Tolerance Limits – A history and the Why, How, What and Where of Implementation in Clinical Trials

      William Andrew Lawton

      • Director / Consultant
      • Risk Based Approach Ltd, United Kingdom
      Hiromichi  Isaka

      Hiromichi Isaka

      • Office of Non-clinical and Clinical Compliance
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Yumi  Sugiura, MRCP

      Yumi Sugiura, MRCP

      • Senior Central Monitor, Global Data Strategies and Solutions
      • Bristol-Myers Squibb K.K., Japan

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Fax: +81-3-3278-1313