Drug Evaluation Committee Approaches to QMS Implementation for Clinical Trial Sponsors - Fostering a Culture of Quality and Demonstrating Leadership
Clinical Evaluation Subcommittee
September 2024
The Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Clinical Evaluation Subcommittee Task Force 2 in 2023 proposed "Fostering a Culture of Quality" and "Demonstrating Leadership" as important elements for sponsor QMS implementation, and provided examples of approaches for solving issues related to sponsor quality management. The "Approach to QMS Implementation for Clinical Trial Sponsors - Fostering a Culture of Quality and Demonstrating Leadership" was prepared for the purpose of presenting examples of approaches to solving issues related to quality management for clinical trial sponsors.
In addition, the results of a survey of the status of QMS initiatives within Task Force 2 are also included as an appendix.
[Image of QMS Implementation by Fostering a Culture of Quality and Demonstrating Leadership
This document assumes that the main target audience is QMS staff responsible for organizational-level quality management initiatives at sponsors, but top management who direct and manage organizations involved in clinical trials and practitioners involved in study-level quality management initiatives also play an important role in implementing a QMS. However, top management who direct and manage the organizations involved in clinical trials and practitioners involved in study-level quality management initiatives also play an important role in implementing a QMS.
We hope this publication will help sponsors implement QMS.
Japan Pharmaceutical Manufacturers Association
Drug Evaluation Committee Clinical Evaluation Subcommittee
2023 Task Force 2