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The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan 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 2023” for officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals, especially in the field of pediatrics. This seminar will be held in-person at the PMDA Office in Tokyo from July 10 to 13, 2023.
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 the 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.
Regulators ONLY (Intermediate level)
See the program (attached)
Participating regulatory authorities may request individual meetings with PMDA and FDA. These meetings will allow participating agencies to ask specific questions related to their agencies. Each meeting will be for 30 minutes.
Number of participants: approx. 30
Close of registration application: April 10, 2023
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/pediatric2023
There is no registration fee for this seminar.
Information on travel and hotel reservation assistance will be provided to the approved participants.
Travel health insurance is not covered by PMDA but PMDA strongly recommends participants consider obtaining it on your own.
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:
For more information, please contact:
Secretariat, PMDA Asia Training Center
Division of Training Center Management
Office of International Programs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
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