Click here to see the Promotion Flyer [621KB]
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC Pediatric Review Seminar 2025” for officials of new drug application reviewers from overseas regulatory authorities. The seminar will be held IN PERSON at the PMDA Office in Tokyo from June 9 to 12, 2025.
The seminar will cover topics relating to the current pediatric guidelines and practices. The lectures and Q&A sessions are delivered by PMDA and international regulators, and the case studies consisting of small group discussions are planned.
The aim of the seminar is to provide participants with opportunities to take a fresh look at their own regulatory systems and to gather additional information that may enhance the review of pediatric drug development programs within their own regulatory frameworks. The training program consists of basic to intermediate level of sessions for 3 days and advanced level of sessions for 1 day.
The seminar is not open to industry or non-regulatory authorities. Participation from many regulatory authorities is welcomed.
Key Objectives of this Seminar
- To learn the scientific, ethical and regulatory considerations when evaluating drug products being developed for the pediatric population
- To learn the global standard guidelines relating to the review of drug products being developed for the pediatric population
- To learn the current practice in the review of drug products being developed for the pediatric population
- To learn the Modeling and Simulation for pediatric drug development
Who should apply
Regulators ONLY (Intermediate level)
- Employees of regulatory authorities with working experience of pharmaceuticals review, particularly in the pediatric field for over 5 years.
- English will be used in the lectures and discussions during the seminar. Participants need an ability to readily communicate in English.
- All participants are recommended to learn the pre-learning materials before participating in the seminar.
Date / Time
- June 9 (Monday), 2025 : 10:00 to 16:15 JST (UTC+9)
- June 10 (Tuesday), 2025 : 10:00 to 16:10 JST (UTC+9)
- June 11 (Wednesday), 2025 : 10:00 to 16:20 JST (UTC+9)
- June 12 (Thursday), 2025 : 10:00 to 15:10 JST (UTC+9)
Program (subject to change)
See the attached program [228KB]
Application (Registration Closed)
Number of participants: approx. 30
Close of registration application: March 19, 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://www12.webcas.net/form/pub/pmda-atc/pediatric2025)
- 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.)