The addendum to ICH E11 entitled, Clinical investigation on medicinal products in the pediatric population (E11), issued as Step 4 in 2017, highlights the recent advances in scientific and technical knowledge in pediatric medicinal product development. To further disseminate information on pediatric drug development (as part of medicinal product development), the Food and Drug Administration of the United States (U.S. FDA) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan are pleased to announce the joint “PMDA-ATC & U.S. FDA Pediatric Review Seminar 2019” at the PMDA Office in Tokyo on July 8-11, 2019. This seminar is intended for regulatory authority officials who are engaged in the review of pediatric drug development programs.
The seminar will cover current pediatric guidelines and practices in the United States and Japan, and will provide the opportunity for the participants to share current pediatric guidelines and practices in their respective countries and regions. Case study sessions on pediatric drug development programs are also planned for small group discussions among the participants.
The aim of the seminar is to provide opportunities for the participants to review their own programs 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 the industry or non-regulatory authorities. Participation from many regulatory authorities is welcomed.
The training will be provided in English (with consecutive translation in some sessions). All participants are expected to actively participate in all the sessions.
By participating in this seminar, the participants will understand:
July 8 to 11, 2019
See the draft 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 30 minutes.
Number of participants: approx. 30
Close of registration: April 12, 2019.
There is no registration fee for this seminar.
Information on travel and hotel reservation assistance will be announced to the approved participants.
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
Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
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