PMDA-ATC & U.S. FDA Pediatric Review Seminar 2026
The PMDA-ATC & U.S. FDA Pediatric Review Seminar 2026 was held from June 23 to 25, 2026. Designed for regulatory agency officials involved in the review and regulation of pediatric medicines, the seminar brought together 27 participants from Bangladesh, Egypt, India, Indonesia, Lao PDR, Malaysia, Philippines, Sri Lanka, Thailand and Uzbekistan.
The seminar opened with welcome remarks from Dr. KONDO Emiko, Executive Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, PMDA, and Dr. Shetarra Walker, Lead Physician at the Division of Pediatric and Maternal Health, CDER from U.S. FDA.In their opening remarks, the speakers welcomed the participants, and expressed their hope that the seminar will deepen participants' understanding of special considerations in the development and evaluation of pediatric drugs.
Lectures covered a wide range of topics including the development of pediatric medicines, pediatric drug regulations in Japan, the U.S. and EU, an overview of the ICH E11 guideline, development strategies incorporating extrapolation from existing adult data, assessment of pediatric clinical data, and ethical considerations in pediatric clinical trials. The seminar also featured a round table discussion, during which participants gave presentations on pediatric drug regulations and vaccination programs in their respective countries, providing an opportunity to exchange experiences and perspectives. In addition, the program included case studies that enabled participants to apply concepts related to the assessment of pediatric clinical study data and ethical considerations in pediatric clinical trials. (see the program for details[181KB])
A total of 15 lecturers and facilitators participated, from Institute of Science Tokyo Hospital, representatives from U.S. FDA and EMA and PMDA staff. Participants were awarded digital certificates.
Through this seminar, PMDA-ATC reaffirmed the commitment to supporting regulatory capacity building and promoting international collaboration in the field of pediatric medicines.
opening ceremony
case study 1 faculty case study 2 faculty
case study discussions
Comments from participants:
“The seminar was very informative, well organized, and easy to follow. The presentations and case studies provided valuable knowledge on pediatric drug development and regulatory review.”
“I really enjoyed the seminar. It was very informative and provided valuable insights”
“It was very challenging, going through a lot of data within the limited timeframe; however, it was very effective and liked the experience.”
“Compare the available guidelines and process in my country with what I learned and give my suggestions to rectify the gaps”
“The knowledge gained from this seminar will be useful for my work in evaluating biological product applications.”
