PMDA-ATC Pharmaceuticals Review Webinar 2022

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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 2022" 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 new drug review and orphan drugs review, as well as the generic drug review through live lectures, question & answer (Q&A) sessions, and case studies consisting of small group discussions among participants.
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
   • Review of orphan drugs
2. To utilize the knowledge learned from the webinar to enhance the regulatory system in the participant’s own organization.

Who should apply

Regulators ONLY (Beginner to Intermediate level)

• 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.
• Attendees who can participate in both of the following time slots.
  1. Prelimiary session
     ‐for internet access confirmation and a brief explanation about the webiner as well as for a team building of the  group like self-introduction,etc. to be held on Tuesday, November 29.
  2. All of the LIVE sessions
     ‐starting at 2:00 P.M. Japan Standard Time (JST) during the webinar period of December 6 to December 8.

Other Points to Note

• The training will be provided in English (with consecutive translation in some sessions).
• All participants should take the PMDA-ATC E-learning Course (Pharmaceuticals Review) (about 98 minutes in total) before attending the live sessions.
• All sessions will be conducted using the Cisco Webex Meeting system.
• Please confirm the attached system requirements.

Date / Time

<Preliminary session>

• November 29 (Tue), 2022   2:00 P.M. -3:00 P.M. JST  (UTC+9)

<LIVE Webinar>

• December 6 (Tue), 2022    2:00 P.M. – 3:50 P.M. JST  (UTC+9)
• December 7 (Wed), 2022    2:00 P.M. – 4:55 P.M. JST  (UTC+9)
• December 8 (Thu), 2022    2:00 P.M. – 4:10 P.M. JST  (UTC+9)

Program (subject to change)

See the program (attached)

Application (Registration closed)

Number of participants: approx. 30
Close of registration: October 11, 2022
In order to attend the webinar, please be sure to submit both of the following applications.

1. PMDA-ATC Pharmaceuticals Review Webinar 2022
   • To attend the webinar, 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/pharm2022
   • Confirmation of the registration and additional information on the webinar will be sent to the approved participants after closing the application.
2. PMDA-ATC E-learning Course (Pharmaceuticals Review)
   • If you have not teken 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-learning02
     *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 for the webinar exceed the upper limit of 30, PMDA, at its discretion, will select the participants based on the information provided in the application form. The applicants who have completed the PMDA-ATC E-learning Course (Pharmaceuticals Review) may have higher priority in the selection.
   • Confirmation of the registration and additional information will be sent to the approved participants after the close of application.

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 International Program
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan

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