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PMDA-ATC GMP Inspection Seminar 2024

bannar of the seminar
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Click here to see the Promotion Flyer [569KB]

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC GMP Inspection Seminar 2024" for officials from overseas regulatory authorities who are engaged in GMP inspection of pharmaceuticals. This seminar will include in-person lectures and plant tour at a manufacturing site in Japan from October 8 to 10, 2024.

Key Objectives of This Seminar

  • To learn regulations of GMP Inspections, especially on the following points.

-GMP Regulation in Japan

-Points on GMP inspection of drug substance manufacturing including on-site inspection and document-based inspection

-Manufacturer’s efforts on pharmaceutical quality issues

  • To utilize the knowledge learned from the seminar in the GMP system of the participant’s own country.

Who should apply

Regulators ONLY (Beginner to Intermediate level)

  • Employees of regulatory authorities with working experience of GMP inspection of pharmaceuticals for over 2 years.
  • Basic knowledge of the regulations pertaining to GMP in your organization is required.
  • ​English will be used in the lectures and discussions during the seminar. Participants need an ability to readily communicate in English.

Date / Time

  • October 8 (Tuesday), 2024 : 9:00 to 17:00 JST (UTC+9)
  • October 9 (Wednesday), 2024 : 9:00 to 17:00 JST (UTC+9)
  • October 10 (Thursday), 2024 : 9:00 to 17:00 JST (UTC+9)

Program (subject to change)

See the attached program [169KB]

Application (Registration closed)

Number of participants: approx. 15
Close of registration application: July 9, 2024
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 head of the organization, before the closing date.

Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/gmp2024

  • If applications exceed the upper limit of 15, selection of the participants will take place at the discretion of PMDA.
  • Confirmation of registration and additional information will be sent to the approved participants after the closing date.

Others

  • Materials will be provided electronically. Participants are recommended to bring their own personal computer to access these materials when needed.

Fee

There is no registration fee for this seminar.

  • Information on travel and hotel reservation assistance will be announced to the approved participants.
  • International travel insurance is not covered by PMDA, but PMDA strongly recommends participants to consider obtaining it on your own.

Seminar Location

A manufacture’s site in Toyama prefecture

Contact Us

For more information, please contact:

Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC[at]pmda.go.jp

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

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