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PMDA-ATC Pharmaceuticals Review Webinar 2023

Click here to see the Promotion Flyer

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC Pharmaceuticals Review Webinar 2023" for officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals. This webinar will be held virtually using Cisco’s WebEx program from September 26 to 28, 2023.
The webinar will cover topics relating to regulations on review for new drugs, biosimilars and generic drugs, etc. Group discussions among participants on case studies are planned as well.
The webinar is not open to the industry or non-regulatory authorities. Participation from many regulatory authorities is welcomed.

Key Webinar Objectives

  1. To learn the key regulatory flow of the pharmaceutical development from clinical trial to approval.
  2. To obtain an opportunity to discuss how to enhance regulatory system for pharmaceuticals review.

Who should apply

Regulators ONLY (Beginner to Intermediate level)

  • Regulatory officials or relevant agencies/institutes employees with at least 3 years of experience in pharmaceuticals review.
  • Participants need an ability to readily communicate in English because the training is provided in English. (with English-Japanese consecutive translation)

Date / Time

  • September 26 (Tuesday), 2023    14:00 to 15:50 JST  (UTC+9)
  • September 27 (Wednesday), 2023    14:00 to 16:40 JST  (UTC+9)
  • September 28 (Thursday), 2023    14:00 to 16:00 JST  (UTC+9)

Program (subject to change)

See the program (attached)

Application  (Registration closed)

Number of participants: approx. 30
Close of registration: July 25, 2023

To apply for the seminar, please make sure to complete 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/pharm2023
 

  • If applications exceed the maximum capacity, selection of the participants will take place at the discretion of PMDA. Participants will be selected from the person who have completed the PMDA-ATC Pharmaceuticals Review E-learning Course on a priority basis.

Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/e-learning02

  • Confirmation of registration and additional information will be sent to the approved participants after the closing date.

Others

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

Fee

There is no registration fee for this webinar. 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
Office of Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs
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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