Click here to see the Promotion Flyer [374KB]
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC MRCT/GCP Inspection Seminar 2025” for officials of new drug application reviewers from overseas regulatory authorities. This seminar will be held IN PERSON at the PMDA Office in Tokyo from January 21 to 24, 2025.
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 drug development and convergence of regulations by sharing accumulated experiences of Japan, such as GCP inspection, protocol designing and planning of MRCT, clinical 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 key points of GCP inspection
- To learn operation of MRCT
- To enhance harmonization on MRCTs and GCP inspection in Asia
- To extend knowledge about recent trend of MRCT and promoting MRCT in Asia
Who should apply
Regulators ONLY (Intermediate level)
- Senior clinical reviewers with at least 3 years of hands-on experience in the assessment of clinical trial applications, benefit-risk profiles for market approvals.
- 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 21 (Tuesday), 2025 : 10:00 to 16:10 JST (UTC+9)
- January 22 (Wednesday), 2025 : 10:00 to 15:50 JST (UTC+9)
- January 23 (Thursday), 2025 : 10:00 to 15:50 JST (UTC+9)
- January 24 (Friday), 2025 : 10:00 to 13:00 JST (UTC+9)
Program (subject to change)
See the attached program [155KB]
Application (Registration closed)
Number of participants: approx. 30
Close of registration application: October 22, 2024
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://www12.webcas.net/form/pub/pmda-atc/mrct2025
- 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
Pharmaceuticals and Medical Devices Agency (PMDA):
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
Please use public transportation. Nearest Tokyo Metro Subway Stations:
- 5 minutes’ walk from Exit 11 of Toranomon Station on the Ginza Line
- 8 minutes’ walk from Exit 3 of Kokkai-gijido-mae Station, on the Marunouchi Line, Chiyoda Line
- 8 minutes’ walk from Exit A13 of Kasumigaseki Station, on the Marunouchi Line, Chiyoda Line, Hibiya Line
- 10 minutes’ walk from Exit 8 of Tameike-sanno Station, on the Ginza Line, Namboku Line
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.)