Click here to see the Promotion Flyer[410KB]
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC GMP Inspection Webinar 2024" for officials from overseas regulatory authorities who are engaged in GMP inspection of pharmaceuticals. This webinar will be held virtually from February 6 to 7, 2024.
Key Objectives of this Webinar
- To learn regulations of GMP Inspections, especially on the following points.
- GMP Regulation in Japan
- Introduction of international reliance by PMDA and other regulatory authorities
- PMDA’s efforts on pharmaceutical quality issues
- Inspectional observation
- Industries’ efforts on pharmaceutical quality issues
- 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)
- Staff 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
- February 6 (Tuesday), 2024 : 14:00 to 17:15 JST (UTC+9)
- February 7 (Wednesday), 2024 : 14:00 to 17:00 JST (UTC+9)
Program (subject to change)
See the attached program[220KB]
Application (Registration closed)
Number of participants: approx. 30
Close of registration application : December 5, 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/gmp2024
- If applications exceed the upper limit of 30, 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
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[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
(Note: For the purpose of security, @ in the E-mail address is replaced with [at]. Please replace [at] with @ when you send an E-mail.)