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Report of the PMDA-ATC & U.S. FDA Pediatric Review Webinar 2021

PMDA-ATC & U.S. FDA Pediatric Review Webinar 2021

From September 21 to 24, 2021, PMDA held a webinar entitled “PMDA-ATC & U.S. FDA Pediatric Review Webinar 2021“. This webinar was intended for officials of overseas regulatory agencies involved in the review of pediatric clinical trial applications and drug applications for pediatric populations. A total of 32 regulators from Azerbaijan, Brazil, India, Indonesia, Malaysia, Myanmar, Nigeria, Peru, Philippines, Sri Lanka and Taiwan, joined the webinar.


In addtion to PMDA, lecturers were invited also from U.S. FDA and European Medicines Agency (EMA). Recorded lectures by staff members from PMDA and the U.S. FDA were provided in advance of the webinar as preliminary training materials, which then were followed during the live webinar by Question & Answer sessions. The lectures covered an overview of a new drug application from  PMDA and the U.S. FDA,  U.S. Pediatric Regulations, physiology and clinical pharmacology in pediatric populations, extrapolation of efficacy from other population data (e.g. adults, foreign child), and ethical considerations for clinical trials in children.


The webinar live session opened with remarks by Mr. UZU Shinobu, Director of PMDA-ATC followed by Dr. ALEXANDER John of U.S. FDA and Dr. SAKIYAMA Michiyo, PMDA Webinar coordinator.


On the second and third day, the attendees worked in groups exploring case studies provided by PMDA and the U.S. FDA on such topics as the review of a pediatric application, extrapolation and ethical issues in pediatric clinical trial design. There was also a wrap-up Q&A session on the final day, with participation of PMDA, U.S. FDA and EMA, which provided a multifaceted learning opportunity for the participants. The participants actively engaged in all discussions.


At the end of the seminar, Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA handed the course completion certificate to each participant virtually by recorded video.

< Program > see the attachment.


Photos and Comments

< Lectures >

“I got new knowledge on the basic points in pediatric drug development and I got some idea for implementing the use of existing knowledge in pediatric drug.”
“The presentation was a very good one and it touched so many grey areas.”
“This session provides useful information about PK/PD evaluation.”
“The presentation was very insightful, amazing and full of relevant information that broadened my knowledge.”
“Comprehensive and relevant discussion on pediatric clinical trials.”
“It was excellent to get an insight from EMA on promoting pediatric drug development.”

< Case Studies  -PMDA>

“Case Study was very good for practical understanding of evaluation of clinical trial protocol for the extrapolation of data for the approval.”
“It is interesting to discuss with other attendee about review process.”
“The presentation is very clear and adds to my knowledge about pediatric review in diabetic disease.”

< Case Studies  -U.S. FDA>

“The case study was very informative. The potential considerations in the evaluation of Clinical Trial protocol for pediatric patients were discussed.”
“It is very informative and giving practical hand on experience for handling clinical trial protocols considering ethical issues for pediatric population.”
“The case study was an insightful one, I was able to have a practical knowledge on the ethical analysis of a protocol.”

<Group Photo>
Opening & closing


<Overall comments>

"The lessons are very technical and very comprehensive. The case studies are difficult but also fun. Thank you very much for this opportunity!"
"The webinar is a good platform to gather every different RA around the world for knowledge and experience sharing in pediatric drug development."
"From this webinar, I got a lot of beneficial knowledge and improve my insight as well, and also I can meet other collegues from other countries. Hopefully this knowledge and experience can be useful for  my job in evaluating drugs so that can be even better in the future."
"Case study impacts a lot, so the webinar may design in a way the case study remain in dominance."

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