Drug Evaluation Committee
Lecture "QMS and its approach to implementation at medical institutions and sponsors - Basics and implementation of QMS that each individual understands:
The Importance of "Fostering a Culture of Quality" and "Demonstrating Leadership""
Feb 06, 2025
The purpose of the Clinical Evaluation Subcommittee TF-2 in 2024 is to propose important elements for QMS implementation to all parties involved in clinical trials and to deepen each person's understanding of the basic concept of QMS and QMS at medical institutions and sponsors in order to ensure appropriate quality in line with the objectives of clinical trials. The lecture meeting was held on January 23, 2025.
In the lecture topic 1), the Clinical Evaluation Subcommittee introduced the basic contents of QMS as well as an overview of the deliverable ( "Approaches to QMS Implementation by Clinical Trial Sponsors: Fostering a Culture of Quality and Demonstrating Leadership"), which was released in September 2024.
In Subject 2, Ms. Kotone Matsuyama, Specially Appointed Professor of Medical Administration, Nippon Medical School
, who is involved in clinical research planning and implementation support in investigator-initiated clinical trials in addition to her position as a medical institution, introduced approaches to quality management at medical institutions.
The main target audience for this lecture is all those involved in clinical trials at medical institutions/SMOs and pharmaceutical companies/CROs (e.g., study planners, monitors, quality management personnel, and personnel in charge of clinical trials at medical institutions (e.g., physicians in charge of clinical trials, CRCs, clinical trials office staff)).
Please click below to view the video of the day's lectures.