Click here to see the Promotion Flyer [1.42MB]
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce that two webinars for medical devices will be held for officials from overseas regulatory authorities who are engaged in the review of medical devices. These webinars will be provided by online live sessions.
- “APEC CoE Workshop: PMDA-ATC Medical Devices Workshop 2024" From October 29 to 30, 2024
This webinar is held as the workshop of Asia-Pacific Economic Cooperation, Regulatory Harmonization Steering Committee (APEC-RHSC) Center of Excellence, however, the webinar is open to non-APEC economies as well.
The webinar will be a basic course with covering explanation of/insight into the IMDRF documents, such as regulations, product reviews, QMS (Quality Management System), safety measures, standards, etc. Small group discussions among participants on case studies are planned as well.
- “PMDA-ATC Medical Devices Webinar 2024" From October 31 to November 1, 2024
This seminar will cover implementation and adaptation of Japanese medical device regulation based on GHTF/IMDRF documents, such as IVD (In Vitro Diagnostics), Software as a Medical Device (SaMD), review of high risk medical devices, etc. Small group discussions among participants on case studies are planned as well.
Trainees will have chances to know recent practical application of international standards in PMDA that may enhance the regulatory systems for medical devices within your own regulatory framework.
Please be noted that this seminar is NOT an “APEC Center of Excellence (CoE) workshop” which follows the core curriculum of the RHSC Medical Devices Priority Work Area (PWA).
Key Objectives of this Webinar
- “APEC CoE Workshop: PMDA-ATC Medical Devices Workshop 2024"
- To learn basics of medical device regulations and the key regulatory flow of the review of medical devices, especially on the following points, based on IMDRF/GHTF documents.
Product classifications based on risk level
Scientific reviews
Safety measures
- To learn points of QMS inspection for medical devices.
- To utilize the knowledge learned from the webinar to enhance the regulatory system in the participant’s own organization.
- “PMDA-ATC Medical Devices Webinar 2024"
- To learn regulations of specific medical devices, especially in the following fields.
IVD medical devices
SaMD
AI-based medical devices
High risk (Classes C and D) medical devices
- To obtain up-to-date information about some specific medical devices of high interest.
- To utilize the knowledge learned from the seminar 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 medical devices and in vitro diagnostics.
- Basic knowledge of the regulations pertaining to the medical devices product review 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
- “APEC CoE Workshop: PMDA-ATC Medical Devices Workshop 2024"
- October 29 (Tuesday), 2024: 14:00 to 17:30 JST (UTC+9)
- October 30 (Wednesday), 2024: 14:00 to 17:20 JST (UTC+9)
- “PMDA-ATC Medical Devices Webinar 2024"
- October 31 (Thursday), 2024: 14:00 to 17:40 JST (UTC+9)
- November 1 (Friday), 2024: 14:00 to 17:20 JST (UTC+9)
Program (subject to change)
See the attached program for Program APEC CoE PMDA-ATC MD Workshop 2024 [124KB]
See the attached program for Program PMDA-ATC MD Webinar 2024 [120KB]
Application (Registration closed)
Number of participants: approx. 30 for each webinar
Close of application: September 23, 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 supervisor, before the closing date.
Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/md2024
- You can apply for both webinars or only one of them.
- 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 [156KB].
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 addresses are replaced with [at]. Please replace [at] with @ when you send an e-mail.)