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Report of the PMDA-ATC & U.S. FDA Pediatric Review Webinar 2022

PMDA-ATC & U.S. FDA Pediatric Review Webinar 2022

The PMDA held a webinar entitled “PMDA-ATC & U.S. FDA Pediatric Review Webinar 2022,” from September 12 to 15, 2022. This webinar was intended for officials of overseas regulatory agencies involved in reviewing pediatric clinical trial applications and new drug applications for pediatric indications. 28 regulators from Azerbaijan, China, Ethiopia, Ghana, India, Indonesia, Pakistan, the Philippines, Saudi Arabia, Sri Lanka, and Thailand joined the webinar.

In addition to the PMDA, lecturers from the U.S. FDA and the European Medicines Agency (EMA) were also invited. Recorded lectures by PMDA and U.S. FDA staff members were provided before the webinar as preliminary training material. The lectures covered an overview of new drug applications, physiology, and clinical pharmacology in pediatric populations, extrapolation of efficacy from other population data, and ethical considerations for clinical trials among children.

The webinar live session opened with remarks by Mr. UZU Shinobu, Director of PMDA-ATC followed by Dr. Dionna Green, Director, Office of Pediatric Therapeutics, US-FDA.

On the second and third days, the attendees collectively explored case studies provided by the PMDA and the U.S. FDA, on topics such as the review of a pediatric application, modeling and simulation, and ethical issues in pediatric clinical trial design. There was also a wrap-up Q&A session on the final day, in which the PMDA, U.S. FDA, and EMA participated; it provided a multifaceted learning opportunity for the participants, who actively engaged in all the discussions. (See program for details.)

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.

Photos and participants comments

< Opening & Closing >

< Lecturers >

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Comments from the participants:
“I would like to attend more of your webinars since by far the most informative and interactive type of webinar I have attended”.
“It was very informative and interactive session”.
“The content of the webinar was useful for reviewing the pediatric new drug applications”.
“I hope that the next seminar will be in person for better communication”.