Drug Evaluation Committee Lecture held on January 18, 2024
Quality by Design and Consistent Quality Management in Clinical Trials
～From the perspective of both sponsors and investigational sites" "Quality by Design and Consistent Quality Management in Clinical Trials

Feb 02, 2024

TF-2 of the Clinical Evaluation Committee in FY2023 will hold a lecture session on January 18, 2024, with the aim of ensuring quality in clinical trials by ensuring that all parties involved in clinical trials understand the concept of quality by design as described in ICH E8 (R1) and by implementing consistent quality management in clinical trials. It was held on January 18, 2024.

In the lecture topic (1), the Clinical Evaluation Subcommittee presented an overview of the deliverable published in July 2023 ( "Ensuring Effective and Efficient Quality in Clinical Trials Based on the Quality by Design Concept: Aiming for Consistent Quality Management from Planning to Conduct").

In the lecture 2, Ms. Yuki Sasaki, Hokkaido University Hospital, who has introduced and is operating quality management, proposed approaches based on the concept of quality by design from the viewpoint of a medical institution.

The main target audience for this lecture is assumed to be the personnel in charge of clinical trials (e.g., physicians in charge of clinical trials and CRCs) at medical institutions and SMOs, as well as those in charge of trial planning and monitoring (including monitoring team leaders and those in charge of creating monitoring plans) at pharmaceutical companies and CROs. The seminar is intended for those in charge of trial planning and monitoring (including monitoring team leaders, monitoring planners, etc.).

Please click below to view the video of the day's lectures.

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