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

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 4rd annual “PMDA-ATC & U.S. FDA Pediatric Review Webinar 2021.” For 2021, 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 Lecture 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 most regulatory authorities are welcome.
 

Key Webinar Objectives

  1. To learn the scientific, ethical and regulatory considerations when evaluating drug products being developed for the pediatric population.
  2. To learn the global standard guidelines relating to the review of drug products being developed for the pediatric population.
  3. 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 have access to Cisco’s WebEx program and are committed to participating in both the preliminary and LIVE sessions. LIVE sessions will begin on September 21, 2021 at 8 P.M. Japan Standard Time (JST)... See attached for 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 English-Japanease consecutive translation in some sessions).
  • All participants are requested to do self-leaning before the LIVE sessions and actively participate in all LIVE sessions.

Date / Time

< Pre-LIVE self-learning (viewing videos and e-learning >
  •  August 17 - September 16, 2021

< Preliminaly session >
  •  September 14 (Tue), 2021: 20:00 – 21:00 JST (UTC+9)

<LIVE Lectures and Q&A>
  • September 21 (Tue), 2021  : 20:00 – 22:15 JST (UTC+9)
  • September 22 (Wed), 2021  : 20:00 – 22:30 JST (UTC+9)
  • September 23 (Thu), 2021  : 20:00 – 22:30 JST (UTC+9)
  • September 24 (Fri), 2021  : 20:00 – 22:15 JST (UTC+9)

Program (subject to change)

See the program (attached)
 

Application

Number of participants: approx. 30
Close of registration application:  July 20, 2021

  • To attend the webinar, please complete the necessary items on the application form, including the signature by the applicant's supervisor.  Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/pediatric2021
  • Early submission is recommended. After the closing date, any change or addition of participant(s) may not be accepted.
  • If the number of applications exceeds the maximum number of participants allowed, participants will be selected at the discretion of PMDA based on information provided in the application form.
  • After the closing application date, those selected participants will be sent a registration confirmation and additional webinar information.

Fee

There is no registration fee for this seminar. 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

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.)

JCN 3010005007409

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

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