On July 8-11, PMDA convened a seminar entitled “PMDA-ATC & U.S. FDA Pediatric Review Seminar 2019". This seminar was designed for regulatory officials from overseas regulatory authorities involved in the review of pediatric clinical trial applications and/or new/generic drug applications for pediatric populations. A total of 26 participants from Bangladesh, Brazil, Chile, India, Indonesia, Malaysia, Myanmar, Nigeria, Papua New Guinea, Russia, Singapore, Sri Lanka, Thailand and WHO (World Health Organization) joined the seminar. (see agenda for details)
The seminar included lectures by staff members from PMDA, U.S. FDA and academic institutions. The topics included the PMDA Introduction and Updates in Pediatrics, U.S. FDA organizational structure and U.S. pediatric regulations, physiology and clinical pharmacology in pediatric populations, extrapolation of efficacy from other population data (e.g. adults, foreign child), ethical considerations for clinical trials in children, and review of the ICH E11 guideline.
Besides the lectures, group work included case studies to explore topics such as the review of a pediatric application, extrapolation and ethical issues in pediatric clinical trial design. Seminar participants presented information on the pediatric drug development programs in their individual countries/regions. The participants actively engaged in all discussions throughout the seminar.
At the end of the seminar, Dr. Yasuhiro Fujiwara, Chief Executive of PMDA handed the course completion certificate to each participant.
After the seminar, individual agency meetings were held among PMDA/U.S.FDA and participants from six countries & WHO to discuss general issues specific to the participants’ region related to pediatric drug development.
Comments from participants:
For the sessions by PMDA
“It was very interesting to see an overview of pediatric drug development program in Japan. A discussion that raised from presentation was fruitful to think about. I specifically enjoyed the PMDA presentation and topics raised from it.”
“Well informed slides and presenter captured real life situation that capture the interest of participants. Presentation and slides with questions stimulated discussion. Excellent.”
“Presentation gives the idea about the ICH 11 & some idea about the usage of existing knowledge in pediatric development in our country.”
For the session on pediatric drug development program of each country
“Each country explain the condition of developing pediatric program clearly. Template of presentation helps us to understand to compare the condition of each country. Discussion is very interesting.”
For the session on clinical pharmacology in pediatric population
“It was excellent, the presenter delivered presentation very clearly with some quiz, so it help us to understand more about physiology and clinical pharmacology in pediatric population.”
For the sessions by U.S.FDA
“Good resource and regulatory expertise as well as numbers of new legislations which have contributed on safeguard pediatric studies and make pediatric study a priority.”
“It was excellent. She can explain very clear, so we can understand about ethical consideration in pediatric CT.”
“The presenter delivered presentation very clearly, so we can understand how to extrapolate data in pediatric. But we still need more experience to adapt pediatric extrapolation algorithm on evaluation data from pediatric.”
For the session on ICH E11 guideline
“The contents of the training have been prepared for trainees to understand each component of ICH E11 (R1). Excellent presentations.”
Comments from participants:
For the case study by PMDA
“Very interesting case study & different response provided by each group enable us to broader our knowledge in product evaluation.”
“The case study was very interesting and well covered. The discussions and point of views provided by different groups in relation to the questions provides a better understanding on how the cases can be addressed and looked at.”
For the case study by FDA
“It was very useful for us, having discussion is interesting as it is broad our experience. We had an example of a rare disease but with alternative treatment. It will be useful to look at the ethics site if we do not have any alternatives!”
“The case study is very useful and allow us to understand regarding extrapolation of adult data in pediatric population.”
“Very well organized and fruitful seminar. We learned a lot from the different lecturers as well as from the different regulatory authorities. I consider it was an appropriate forum from the regulators and developers.”
“It was a great seminar relevant to the issue (pediatric drug development). It brings knowledge to improve my capacity in evaluating dossier about new drug for pediatric population. And, this knowledge will be shared with my colleagues in my organization.”
“This is a very informative seminar for small agencies like us. Also, from this seminar, we could share & assess the knowledge & practices of the other regulatory agencies. This program is very helpful to benchmark the smaller drug regulatory agencies with stringent regulatory agencies.”
“In general, the seminar is very well conducted. It helps us to understand better on the physiology and clinical pharmacology of the pediatric population and how to use the existing knowledge in pediatric drug development.”
PMDA-ATC Seminars are held periodically, with a different theme for each seminar.
The Seminar announcements are posted on this website.
For any questions regarding PMDA Training Seminar, please contact us by clicking on the “Contact us” logo on top of the website, or please contact the Secretariat (e-mail: PMDA-ATC●pmda.go.jp).