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PMDA-ATC & U.S. FDA Pediatric Review Webinar 2020


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 3rd annual “PMDA-ATC & U.S. FDA Pediatric Review Webinar 2020.” For 2020, this seminar will be held virtually using Cisco’s WebEx program. This will allow officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals, especially in the field of pediatrics, to join from their own countries.  

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 Question & Answer (Q&A) sessions, and case studies consisting of small group discussions among participants and facilitators.

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 the industry or non-regulatory authorities.  Participation from most regulatory authorities are welcome.

Key Webinar Objective

  • 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, e.g., ICH guidelines
  • 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

  • Attendees who can access Cisco‘s WebEx program and participate in all LIVE sessions starting at 8 P.M. Japan Standard Time (JST) during the webinar period via Web browsers. See attached for the system requirements.
  • Employees of regulatory authorities with working experience of pharmaceuticals review, particularly in the pediatric field for over 3 years.

Other Points to Note

  • The training will be provided in English (with consecutive translation in some sessions)
  • All participants are requested to do self-leaning before the LIVE sessions and actively participate in all of the LIVE sessions.

Date / Time

  • Pre-LIVE self-learning (viewing videos and e-learning):

                 September 21-25, 2020

  • LIVE Lectures and Q&A:

                 September 28, 2020    20:00 – 22:00 JST  (UTC+9)
                 September 29, 2020    20:00 – 22:00 JST  (UTC+9)
                 September 30, 2020    20:00 – 22:00 JST  (UTC+9)
                 October 1, 2020           20:00 – 21:00 JST  (UTC+9)  

Program (subject to change)

See attached for the draft program

Registration

Number of participants: approx. 30
Close of registration: August 17, 2020

  • Registration requests should be made by filling in all the necessary items including the signature of the applicant’s supervisor on the application form (attached).Please send the form as a Word file (without signature) and a PDF file (with signature) by e-mail to the e-mail address shown in “Contact Us” below.
  • Early registration is recommended. After the closing date, any change or addition of participant(s) may not be accepted.
  • If there are more applications than available spaces, selection of the participants will take place at the discretion of PMDA based on the information provided in the application form.
  • Confirmation of the registration, connection test and additional information will be sent to the accepted participants after the close of registration.

Fee

There is no registration fee for this webinar.     

Each participating agency is responsible for obtaining computer access to Cisco’s WebEx program (https://www.webex.com/).  

Contact Us

For more information, please contact:

Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC●pmda.go.jp

Office of International Program
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.)

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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