Drug Evaluation Committee Information of "Workshop on the Implementation of the Clinical Trial Ecosystem Declaration 2025" -Convincing Clinical Trial Operations through Dialogue and Review of Japan's Unique Operations with CTQ as a Common Language
Mar 04, 2026
In the fiscal 2024 and 2025 clinical trial ecosystem implementation promotion projects, we have been working with the PMDA and related medical institutions to visualize issues in clinical trial operations and identify directions for improvement. As a result of these efforts, we issued the "Clinical Trial Ecosystem Industry Declaration 2025 (hereafter, Industry Declaration 2025)" in October 2025. Based on the Industry Declaration 2025, we have positioned fiscal 2026 as the year to promote "implementation" and "establishment.
In particular, it is expected that each company will specifically implement clinical trial operations that emphasize dialogue with medical institutions, while utilizing the CTQ as a common language and reviewing excessive operations unique to Japan.
The purpose of this workshop is to deepen participants' understanding and form a common understanding through sharing the background, ideas, and policies of the Industry Declaration 2025.
Please note that the call for participants from JPMA/PhRMA/EFPIA/JCROA has been closed.
We are looking for additional participants from companies that are not members of any of the four organizations, who understand the main purpose of this activity and are willing to work toward its implementation within their companies.
Please note that due to the limited number of participants, we may not be able to accept some participants if there are too many applications. If you are interested in participating, we will arrange a date and time for you to attend the workshop.
A questionnaire will be sent out prior to and after the workshop to help us plan for the future. Your responses will be anonymized to prevent identification of individuals and companies, and the results may be made public in the future. We appreciate your cooperation.
Date and time
Session 1: Wednesday, April 1, 2026, 13:30-17:00 @ Nihonbashi Life Science Hub (face-to-face)
Session 2: Tuesday, April 21, 2026, 13:30-17:00 @ MSD K.K. (face-to-face) *The same content for both sessions.
Format
- Workshop (face-to-face)
- 100 participants per session (40 from companies, 20 from CROs, 10 from medical institutions, 10 from PMDA, 10 from JSQA, 10 from facilitators)
- Content: Group discussion → Summary → Presentation (results to be tabulated at a later date)
Subject of application (slots to be filled in this proposal)
JPMA/PhRMA/EFPIA Japan/JCROA non-member companies: 1 person from each company
Please register using the preliminary questionnaire form below.
Response deadline: Tuesday, March 10, 2026