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Report of the PMDA-ATC & U.S. FDA Pediatric Review Seminar 2018

PMDA-ATC & U.S.FDA Pediatric Review Seminar 2018

  On June 11-14, 2018, the Pharmaceuticals and Medical Devices Agency (PMDA) convened the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) & U.S. Food and Drug Administration (U.S.FDA) Pediatric Review Seminar 2018. This seminar was designed for regulatory officials in charge of review of clinical trial applications and/or new/generic drug applications for pediatric populations from overseas regulatory authorities. Total of 24 regulators from 12 countries/regions (Bangladesh, Brazil, Chile, Indonesia, Malaysia, Papua New Guinea, Philippines, South Africa, Sri Lanka, Taiwan, Thailand and Uganda) joined the seminar.

 The seminar opened with remarks by Dr. Yoshikazu Hayashi, Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, followed by the message from Dr. Michiyo Sakiyama, International Training Coordinator of this seminar of PMDA and Dr. Donna Snyder, Dr. Catherine Lee and Dr. John Alexander of FDA. Subsequent lectures were provided by the staff members from PMDA, U.S.FDA and academic institutions. The topics discussed included the PMDA organizational structure and updates in pediatrics, U.S.FDA organizational structure and U.S. pediatric regulations, physiology and clinical pharmacology in the pediatric population, extrapolation of efficacy from other population data (e.g. adults, foreign child), ethical considerations and review of the ICH E11 guideline. In addition, working groups were actively conducted with participants using a case study approach to discuss the evaluation of pediatric clinical study data. The participants provided the details of the pediatric drug development programs in their own countries/regions and positively engaged in discussions throughout the seminar  (see agenda for details).

 As a new activity, individual agency meetings were held after the daily sessions among PMDA/U.S.FDA and participants from seven countries, to discuss general issues related to pediatric drug development that were specific to the participant's country.

 In total 10 trainers including 5 staff members from PMDA contributed to the lectures and case studies.
 On the final day of the seminar, the Course completion certificates were handed to each participant by Dr. Tatsuya Kondo, Chief Executive of PMDA.

Photos and participant comments

<Lectures>

 Lectures1  Lectures2

 Lectures3  Lectures4

Comments from participants:

For the sessions by PMDA
 “Thank you for highlighting very important misconception in review of paediatric drug and important fundamental concept for the review of paediatric drug.”

 “Very comprehensive presentation. I was able to gain knowledge regarding paediatrics in Japan.”

“It was really interesting, as it was possible to know how PMDA does extrapolation in Japan, also considering the ethnic issue.”

For the session on pediatric drug development program of each country
“It was really interesting to become aware of the current regulation and status of pediatric drugs and clinical trials in each country participating in this seminar.”

For the session on clinical pharmacology in pediatric population
“We got important information about clinical pharmacology in pediatric population. Maybe we can have more longer time for this topic. His presentation can be understood very well and very clear.”

For the sessions by U.S.FDA
“Excellent presentation skill. I was able to gain knowledge U.S. regulations on paediatrics & paediatric drug development.”

 “The presentation provided clear information of how the extrapolation (pediatric) works in U.S.! Also, it was interesting to know about the number (%) of extrapolations that have occurred in U.S.”

“It is interesting to be aware of ethical consideration in U.S. Certainly is an important point to consider in pediatric clinical trials.

For the session on ICH E11 guideline
“Very informative and this is very new for me. Actually although we don’t have specific Act on pediatric clinical trials process, this pediatric extrapolation and E11 Guidelines are very useful. In Sri Lanka, we do clinical trials for pediatric population and we can obviously share this knowledge in our NRA staff.”

<Case studies>

 Case studies1  Case studies2

 Case studies3  Case studies4

Comments from participants:

For the case study by PMDA
“The case study was really important to understand how each regulatory agency evaluate the case and the opinion about the results provided by MAH. The activity was really helpful and impact directly in my routine in our agency.”

 “The case study was very useful to understand the issues regarding evaluation of data for supporting drug application. “

For the case study by FDA
 “The case studies were very helpful to have knowledge of type of extrapolation in U.S. based on “real” data/studies. It would be interesting to have in future seminars a case study to be evaluated by the participants and document it on a group.”

<Group photo>

 Group photo

Overall comments from the participants

Comments from participants:

“The seminar was excellent to gain knowledge of pediatric drug development. I particularly enjoyed the case studies from PMDA and U.S.FDA, as we could understand how the approaches for clinical data review are.”

“The seminar was very informative and it would be very useful for our agency. The views of PMDA and FDA about pediatric review is very useful to provide further discussion about the topic inside each region that is participating on the seminar. For all the seminar fulfilled my expectations.”

“It briefly introduce me to extrapolation term in pediatric drug evaluation. The presentations are good enough to elaborate the topic and provided a lot of information and also case studies that make me understand easier. The discussion session is very helpful to increase and clarify our understanding.”

“The main topic area is not considered in selecting medicines in our part of the world. So this is an “eye opener.””


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).

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