APEC CoE Workshop: PMDA-ATC Medical Devices Workshop 2023

Click here to see the Promotion Flyer

Introduction

 The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “APEC CoE Workshop: PMDA-ATC Medical Devices Workshop 2023" for officials from overseas regulatory authorities who are engaged in the review of medical devices. This webinar will be held virtually from November 14 to 16, 2023.
 The webinar is held as the workshop of Asia-Pacific Economic Cooperation, APEC 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, safety measures, standards, etc. Small group discussions among participants on case studies are planned as well.

Key Objectives of This Seminar

1. 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
   • Clinical evaluation
   • Safety measures
2. To obtain up-to-date information about international regulatory harmonization effort for medical devices (utilization of international standards, IMDRF, etc.).
3. 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)

• 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

• November 14 (Tuesday), 2023:   14:00 to 17:40 JST (UTC+9)
• November 15 (Wednesday), 2023:  14:00 to 17:10 JST (UTC+9)
• November 16 (Thursday), 2023:   14:00 to 16:50 JST (UTC+9)

Program (subject to change)

See the program (attached)

Application (Registration closed)

Number of participants: approx. 30
Close of registration application : October 1, 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/md2023_coewsrev1

• If applications exceed the upper limit of 30, selection of the participants will take place at the discretion of PMDA.  Participants will be selected from the person who have completed the PMDA-ATC Medical Devices Review E-learning Course on a priority basis.

Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/e-learning02

• 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●pmda.go.jp

Office of 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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