PMDA-ATC Pediatric Review Seminar 2025
The PMDA-ATC Pediatric Review Seminar 2025 was organized June 9 to 12, 2025. Designed for regulatory agency officials, it was attended by 26 participants from Bangladesh, Brazil, Cuba, Egypt, Hong Kong, Indonesia, Malaysia, Pakistan, Papua New Guinea, the Philippines, Sri Lanka, Thailand and Uzbekistan.
The seminar opened with welcome remarks from Dr. KONDO Emiko, Senior Executive Director of PMDA, Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs. Dr Kondo also concluded the seminar.
Lectures covered a wide range of topics including the development of pediatric medicines, pediatric drug regulations in Japan, the US and EU, an overview of the ICH E11 guideline, extrapolation in the utilization and evaluation of existing knowledge (such as adult data) in pediatric drug development, clinical pharmacology, modeling and simulation, and practical considerations when utilizing existing knowledge in pediatric drug reviews.
External lecturers shared perspectives on formulation challenges for pediatric patients, drug development in industry, and pediatric care in clinical settings.
The program also included a case study on the evaluation of pediatric clinical study data, participant-led sharing sessions on pediatric regulations in different countries and pediatric vaccination practices, and an online Q&A session with the US Food and Drugs Administration (FDA). (program link [119KB])
A total of 22 lecturers and facilitators participated, from National Center for Child Health and Development, Omori Medical Center of Toho University, industry, representatives from US FDA and EMA and PMDA staff. Participants were awarded a digital certificate.
Comments from the participants:
“The seminar was enjoyable, lectures informative and very well organized. Appreciated the clear explanation of regulatory perspectives.”
"Information will be shared with my network in my country and will help shape policies to improve pediatric drug development.”
“Utilization of DCTs to promote pediatric clinical trials could be suggested”
“If I have the opportunity to develop the pediatric drug development framework, I will apply this knowledge.”
