Click here to see the Promotion Flyer [269KB]
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC Multi-Regional Clinical Trial (MRCT)/Good Clinical Practice (GCP) Inspection Seminar 2026” for officials from overseas regulatory authorities. This seminar will be held IN PERSON from January 27 to 30, 2026 in Tokyo.
This seminar is held as the workshop of Asia-Pacific Economic Cooperation, Regulatory Harmonization Steering Committee (RHSC) Center of Excellence.
The seminar aims to promote clinical trials for drug development and convergence of regulations by sharing accumulated experiences of Japan, such as GCP inspection, protocol designing and planning of MRCT, clinical trial operation and clinical data evaluation, and discussing clinical trial networking with participants from around the world.
Key Objectives of This Seminar
- To learn design and evaluation of MRCTs
- To learn operation of MRCT by sponsor and academia perspective
- To learn key points of GCP inspection
- To enhance the international harmonization on MRCTs and GCP inspection
- To extend knowledge about recent trend of MRCT and promoting MRCT in Asia
Who should apply
Regulators ONLY (Intermediate level)
- Senior reviewers of clinical trials with at least 3 years of hands-on experience or.
- Senior inspectors for GCP with at least 3 years of hands-on experience.
- English will be used in the lectures and discussions during the seminar. Participants need an ability to readily communicate in English.
- Regulators from non-APEC economies are also welcomed.
Date / Time
- January 27 (Tuesday), 2026 : 10:00 to 16:30 JST (UTC+9)
- January 28 (Wednesday), 2026 : 10:00 to 15:50 JST (UTC+9)
- January 29 (Thursday), 2026 : 10:00 to 15:50 JST (UTC+9)
- January 30 (Friday), 2026 : 10:00 to 13:20 JST (UTC+9)
Program (subject to change)
See the attached program [97KB]
Application
Number of participants: approx. 30
Close of registration application: October 31, 2025
To apply for the seminar, please make sure to complete all the necessary items on the application form, including the signature by the applicant's head of the organization, before the closing date. Click the link to apply: https://atcform.pmda.go.jp/servlet/front?id=87&p=1&m=1
- If applications exceed the upper limit of 30, selection of the participants will take place at the discretion of PMDA.
- Confirmation of registration and additional information will be sent to the approved participants after the closing date.
Others
- Materials will be provided electronically. Participants are recommended to bring their own personal computer to access these materials when needed.
Fee
There is no registration fee for this seminar.
- Information on travel and hotel reservation assistance will be announced to the approved participants.
- International travel insurance is not covered by PMDA, but PMDA strongly recommends participants to consider obtaining it on your own.
Seminar Location
Vision Center Tokyo TORANOMON
T-LITE Bldg. 5th floor, 2-4-7 Toranomon, Minato-ku, Tokyo
Contact Us
For more information, please contact:
Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC[at]pmda.go.jp
Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
(Note: For the purpose of security, [at] in the e-mail addresses are replaced with @. Please replace [at] with @ when you send an e-mail.)