日本語
Pmda - Pharmaceuticals and Medical Devices Agency
Menu
Close
Favorite pages
Safety Alert & Recalls/ Review Reports/ Package Inserts etc.
Formats DL
Back
Back
Back

Events and Symposia

PMDA-ATC GMP Inspection Webinar 2021

Add this page to "Favorite pages"
Print the text

Click here to see the Promotion Flyer

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC GMP Inspection Webinar 2021" for officials from overseas regulatory authorities who are engaged in GMP inspection of pharmaceuticals.
The webinar is offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) by using the Cisco WebEx Meeting system.
The webinar will cover topics relating to the current Japan’s GMP regulations and QRM (Quality Risk Management) through Live Lecture and Question & Answer (Q&A) sessions, and case studies consisting of small group discussions among participants.
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 Japan’s GMP regulation.
  2. To learn basics of risk-based inspection of chemical drugs.
  3. 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 participate in both of the following time slots.
  1. Preliminary session for internet access testing as well as for self-introduction to be held about one week prior to the live session
  2. All of the LIVE sessions starting at 2 P.M. Japan Standard Time (JST) during the webinar period. All sessions will be conducted using the Cisco Webex Meeting system. For the system requirement details see the Cisco Webex Help Center.
  • Employees of regulatory authorities with working experience of GMP inspection for over 2 years.
  • Basic knowledge of the regulations pertaining to GMP in his/her organization is required.

Other Points to Note

  • The training will be provided in English (with consecutive translation in some sessions).
  • All participants are requested to do self-leaning before the LIVE sessions and actively participate in all LIVE sessions.

Date / Time

< Preliminaly session >

  •  November 18 (Thu), 2021 : 2:00 P.M. – 3:00 P.M. JST (UTC+9)

<LIVE Lectures and Q&A>

  • November 25 (Thu), 2021 : 2:00 P.M. – 5:00 P.M. JST (UTC+9)
  • November 26 (Fri), 2021 : 2:00 P.M. – 5:00 P.M. JST (UTC+9)

Program (subject to change)

See the program (attached)
 

Application (Registration closed)

Number of participants: approx. 30
Close of registration: September 23, 2021

  • 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 based on information provided in the application form.
  • After closing the application (Sept. 23), a registration confirmation and additional webinar information will be sent to those selected participants.

Fee

There is no registration fee for this seminar. Each participating agency is responsible for obtaining computer access to Cisco’s WebEx program (https://www.webex.com/).
 

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.)