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 (JPMA) Committee on Drug Evaluation, Clinical Evaluation Subcommittee, Task Force 2 in FY2023 proposed "Fostering a Culture of Quality" and "Demonstrating Leadership" as important elements for QMS implementation by sponsors, and provided examples of approaches to solve issues related to quality management by sponsors. 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
Committee on Drug Evaluation, Clinical Evaluation Subcommittee
2023 Task Force 2
Deliverables of the Drug Evaluation Committee Return to list of all deliverables