PMDA-ATC Pharmaceuticals Review Webinar 2021

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Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Pharmaceuticals Review Webinar 2021" for officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals.
The webinar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) and will be held virtually using Cisco’s WebEx program.
The webinar will cover topics relating to the regulatory process from clinical trial to approval, review of new drugs and generic drugs, etc.
The aims of the webinar are to provide chances for the participants to take a fresh look at their own programs and to gather additional information that may enhance the review systems for pharmaceuticals within their own regulatory framework.
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 product development.
   The webinar will focus on the following key regulatory activities.
   - Regulatory process from clinical trial to approval
   - Review of new drugs
   - Review of generic drugs
2. To utilize the knowledge learned from the webinar to enhance the regulatory system in the participant’s own organization.

Who should apply

• Attendees who can access to “Cisco Webex” and are committed to participating in both the preliminary and the LIVE sessions starting at 2 P.M. Japan Standard Time (JST: UTC+9) during the webinar period via Web browsers. For the system requirement details see the Cisco Webex Help Center.
• Employees of regulatory authorities, or other agencies/institutes closely related thereto, who are currently engaged in the review of pharmaceuticals.
• Pharmaceutical reviewer with at least 3 years of experience in the review of pharmaceuticals.
• Basic knowledge of the regulations pertaining to the pharmaceuticals review in his/her organization is required.

Other Points to Note

• The training will be provided in English (with English-Japanese consecutive translation in some sessions).
• All participants should take the PMDA-ATC E-learning Course (Pharmaceuticals Review) (about 100 minutes in total) before attending the live sessions.

Date / Time

• Preliminaly session

          November 29, 2021   14:00 – 15:00 JST  (UTC+9)

• LIVE Lectures Q&A

          December 6, 2021    14:00 – 15:40 JST  (UTC+9)
          December 7, 2021    14:00 – 16:45 JST  (UTC+9)
          December 8, 2021    14:00 – 16:00 JST  (UTC+9)

Program (subject to change)

See attached the program

Application (Registration closed)

Number of participants: approx. 30
Close of registration: October 4, 2021

• In order to attend the webinar, please be sure to submit both of the following applications.
• PMDA-ATC E-learning Course (Pharmaceuticals Review)
  If you have not applied for the e-learning course, please use the following link to apply and receive your ID/password. Application webpage: https://www12.webcas.net/form/pub/pmda-atc/e-learning01.
  *All participants are required to complete the e-learning course before attending the webinar.
• 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
• 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/), as well as securing an appropriate environment for each participant (stable internet connection, suitable equipment, etc.)

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.)