PMDA-ATC & U.S. FDA Pediatric Review Seminar 2023
The PMDA held a seminar titled “PMDA-ATC & U.S. FDA Pediatric Review Seminar 2023” from July 10 to 13, 2023. This seminar was intended for officials of overseas regulatory agencies involved in reviewing pediatric clinical trial applications and new drug applications for pediatric indications. 25 regulators from Hong Kong, Indonesia, Lao PDR, Malaysia, the Philippines, Saudi Arabia, Taiwan and Thailand joined the seminar.
The seminar opened with remarks by Dr. UZU Shinobu, Director of PMDA-ATC followed by Dr. John ALEXANDER, Deputy Division Director, Division of Pediatric and Maternal Health, US-FDA. In addition to the PMDA, lecturers from the US-FDA and the European Medicines Agency (EMA) were invited. The lectures covered a brief overview of the organization as well as the pediatric regulation update of PMDA, US-FDA and EMA, physiology and clinical pharmacology in pediatric populations, extrapolation of efficacy from other population data, and ethical considerations for clinical trials among children. Seminar participants also presented information on the pediatric drug development programs in their respective countries/regions.
Besides lectures, the attendees collectively explored case studies provided by the PMDA and the US-FDA on topics such as the review of a pediatric application, ethical issues in pediatric clinical trial design, and modeling and simulation. There was also a wrap-up Q&A session on the final day, which provided a multifaceted learning opportunity for the participants
(See program for details.)
The seminar was closed with the remarks by Dr. UZU Shinobu, PMDA and Dr. Shetarra WALKER, Lead Physician, Division of Pediatric and Maternal Health, US-FDA. As a token of active participation in the seminar, the digital certification of “Open Badge” were given to all the participants.
Photos and participants comments
< Opening & Closing >
< Lecturers >
< Participants >
Comments from the participants:
- I would use all the information learned from this seminar during evaluation and other relevant duties at my country.
- It may be applied in terms of development of guidelines regarding pediatric drug development and submission of dossiers, particularly related to safety and efficacy.
- Case study enabled communication within the group. In addition, the activity provided more understanding on the evaluation of safety and efficacy of a drug product in infants comparing with adults as well as between races (Japanese vs. entire population).
- Information on extrapolation approach would really help us with product review.
- The case study was indeed relevant to the lectures and may be applicable in future evaluations back in our home countries.
- It was very useful session. The examples of cases help to understand the simulation and modeling.
