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Events and Symposia

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

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Click here to see the Promotion Flyer

Introduction

 The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan and the Food and Drug Administration of the United States (U.S. FDA) are pleased to announce the “PMDA-ATC & U.S. FDA Pediatric Review Webinar 2022” for officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals, especially in the field of pediatrics.  This webinar will be held virtually using Cisco’s WebEx program.
 The webinar will cover topics relating to the current pediatric guidelines and practices in Japan and the United States through self-learning lecture videos, live lectures and question & answer (Q&A) sessions, and case studies consisting of small group discussions among participants.
 The aim of the webinar is to provide opportunities for participants to take a fresh look at their own programs and to gather additional information that may enhance the review of pediatric drug development programs within their own regulatory frameworks.
 The webinar is not open to industry or non-regulatory authorities.  Participation from many regulatory authorities are welcomed.

Key Webinar Objectives

  • To learn the scientific, ethical and regulatory considerations when evaluating drug products being developed for the pediatric population.
  • To learn the global standard guidelines relating to the review of drug products being developed for the pediatric population.
  • To learn the current practice and issues in the review of drug products being developed for the pediatric population when data are collected in adults and the pediatric population of other races.

Who should apply

Regulators ONLY (Intermediate level)

  • Employees of regulatory authorities with working experience of pharmaceuticals review, particularly in the pediatric field for over 3 years.
  • Attendees who can participate in both of the following time slots.
    1. Preliminary session for internet access confirmation and a brief explanation about the webinar as well as for a team building of the group like self- introduction, etc. to be held on September 5.
    2. All of the LIVE sessions starting at 6:30 P.M. on Day1 and Day2, and  at 7:30 P.M. on Day3 and Day4 Japan Standard Time (JST) during the webinar period of September 12 - 15.

All sessions will be conducted using the Cisco Webex Meeting system.  Please confirm the attached system requirements.

Other Points to Note

  • The training will be provided in English (with English-Japanease consecutive translation in some sessions).
  • All participants should take and complete self-learning lecture videos prior to attending the live session.

Date / Time

< Preliminary Session>

  • September 5 (Mon), 2022    6:30 P.M.– 7:30 P.M. JST (UTC+9)


<Live Webinar>

  • September 12 (Mon), 2022    6:30 P.M. – 8:55 P.M. JST (UTC+9)
  • September 13 (Tue), 2022      6:30 P.M. – 10:10 P.M. JST (UTC+9)
  • September 14 (Wed), 2022    7:30 P.M. – 10:30 P.M. JST (UTC+9)
  • September 15 (Thu), 2022     7:30 P.M. –  9:40 P.M.  JST (UTC+9)

Program (subject to change)

See the program (attached)

Application (Registration closed)

Number of participants: approx. 30
Close of registration application: July 11, 2022

  • To attend the webinar, please make sure to complete the all the necessary items on the application form, including the signature by the applicant's supervisor before the closing date. 
    Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/pediatric2022
  • If applications exceed the upper limit of 30, selection of the participants will take place at the discretion of PMDA. 
  • Confirmation of the registration and additional information will be sent to the approved participants after the closing date.

Fee

There is no registration fee for this seminar.  Any expenses incurred with participation in the webinar will not be covered by PMDA.

Contact Us

For more information, please contact:
Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC●pmda.go.jp
Division of Training Center Management
Office of International Programs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
 
(Note: For the purpose of security, @ in the e-mail addresses are replaced with ●. Please replace ● with @ when you send an e-mail.)