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PMDA-ATC GMP Inspection Webinar 2022

Click here to see the Promotion Flyer

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC GMP Inspection Webinar 2022” for officials from overseas regulatory authorities who are engaged in GMP inspection of pharmaceuticals.  This webinar will be held virtually using Cisco’s WebEx program.
The webinar will cover topics relating to Data Integrity (DI) through Live Lectures and Questions & Answers (Q&A) sessions, as well as a case study consisting of small group discussion among participants.
The webinar is not open to industry or non-regulatory authorities.  Participation from many regulatory authorities is welcomed.

Key Webinar Objectives

  1. To learn basics of Data Integrity.
  2. To utilize the knowledge learned from the webinar to enhance the regulatory system and inspection skill in the participant’s own organization.

Who should apply

  Regulators ONLY (Beginner to Intermediate level)
  • Staff of regulatory authorities with working experience of pharmaceuticals inspection for over 2 years.
  • Basic knowledge of the regulations pertaining to GMP in his/her organization is required.
  • Attendees who can participate in both of the following time slots.
  • Preliminary session
    for internet access confirmation and a brief explanation about the webinar as well as for a team building of the group like self- introduction, etc. to be held at 2:00 P.M. Japan Standard Time (JST) on October 18.
  • All of the LIVE sessions
    starting at 2:00 P.M. (JST) during the webinar period of October 25-26.

Other Points to Note

  • The training will be provided in English (with English-Japanease consecutive translation)
  • All sessions will be conducted using the Cisco Webex Meeting system.
  • Please confirm the attached system requirements.

Date / Time

< Preliminaly session >

  •  October 18 (Tue), 2022 : 2:00 P.M. – 3:00 P.M. JST (UTC+9)

<LIVE Lectures and Q&A>

  • October 25 (Tue), 2022 : 2:00 P.M. – 5:15 P.M. JST (UTC+9)
  • October 26 (Wed), 2022 : 2:00 P.M. – 4:50 P.M. JST (UTC+9)

Program (subject to change)

See the program (attached)

Application (Registration closed)

Number of participants: approx. 30
Close of registration application : August 23, 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.  If the number of applications exceeds the maximum capacity, selection of the participants will take place at the discretion of PMDA.
  • Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/gmp2022
  • Confirmation of the registration and additional information on the webinar will be sent to the approved participants after closing the application.

Fee

There is no registration fee for this seminar.  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

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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