PMDA-ATC & U.S. FDA Pediatric Review Seminar 2024
The PMDA-ATC & U.S. FDA Pediatric Review Seminar 2024 was conducted from July 22 to 25. This seminar was intended for officials from overseas regulatory agencies involved in reviewing pediatric clinical trials and new drug applications. Notably, 21 regulators from Bangladesh, Bhutan, Egypt, Indonesia, Malaysia, Pakistan, Peru, the Philippines, and Thailand participated in the seminar.
The seminar opened with the remarks by Dr. SUZUKI Hiroshi, Executive Director of PMDA.
On the first day, lectures were delivered on the introduction to pediatric drug development and pediatric regulation in Japan, the U.S.A., and the EU. Subsequently, in the roundtable discussion, participants gave presentations on the introduction of pediatric regulations in each country and region. On the second day, lectures were delivered on the ICH E11 guideline, use of existing knowledge (adult study data, etc.) in pediatric drug assessment, and logic of pediatric extrapolation. A case study was conducted to evaluate pediatric clinical study data for application. On the third day, a lecture on practical considerations for using existing knowledge (adult study data, etc.) in pediatric reviews, a lecture, and case study on ethical considerations in pediatric clinical trials were delivered. On the fourth day, a lecture and case study on the modeling and simulation of clinical pharmacology were conducted. In addition to the PMDA, five lecturers from the U.S. Food and Drug Administration (FDA) participated as lecturers and facilitators, as well as one lecturer from the European Medicines Agency (EMA, online). All lecturers shared their expertise with the participants, making the seminar informative and meaningful.
(see the program for details[236KB])
This event was closed with the remark by Dr. KONDO Emiko, the Head of Asia Training Center. As a token of active participation in the workshop, the digital certification of Open Badge was given to the participants.
Photos and participant comments
Comments from the participants:
"The seminar was very informative and learning especially for the growing National Regulatory Authorities. "
"I got to learn new concepts of pediatrics extrapolation and the relevant ICH guidelines associated with it."
"More time to deliberate the answer session after group discussion."
"The provided knowledge will be applied during the review of submitted clinical trials applications."
