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Events and Symposia

PMDA-ATC & U.S. FDA Pediatric Review Seminar 2024

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Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) and the Food and Drug Administration of the United States (U.S. FDA) are pleased to announce the “PMDA-ATC & U.S. FDA Pediatric Review Seminar 2024” 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 July 22 to 25, 2024.

The seminar will cover topics relating to the current pediatric guidelines and practices in Japan and the United States through lectures and Q&A sessions, and case studies consisting of small group discussions among participants.
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 seminar is not open to industry or non-regulatory authorities.  Participation from many regulatory authorities is welcomed.

Key Objectives of This Seminar

  1. To learn the scientific, ethical and regulatory considerations when evaluating drug products being developed for the pediatric population.
  2. To learn the global standard guidelines relating to the review of drug products being developed for the pediatric population.
  3. To learn the current practice and issues in the review of drug products being developed for the pediatric population when data are collected in adults and the pediatric population of other ethnic groups.
  4. To learn basics of 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 3 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 take self-learning lecture videos prior to attending the seminar.

Date / Time

  • July 22 (Monday), 2024         : 10:00 to 16:20 JST (UTC+9)
  • July 23 (Tuesday), 2024        : 10:00 to 16:30 JST (UTC+9)
  • July 24 (Wednesday), 2024   : 10:00 to 16:30 JST (UTC+9)
  • July 25 (Thursday), 2024       : 10:00 to 15:10 JST (UTC+9)

Program (subject to change)

See the program (attached)

Application

Number of participants: approx. 30
Close of registration application: April 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/pediatric2024

  • 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 Marunouchi Line, Chiyoda Line, Hibiya Line
10 minutes' walk from Exit 8 of Tameike-sanno Station, on the Ginza Line, Nanboku Line

Contact Us

For more information, please contact:

Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC●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, @ in the e-mail addresses are replaced with ●. Please replace ● with @ when you send an e-mail.)