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APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2022 - Explanation of/Insight into the IMDRF documents -



Click here to see the Promotion Flyer

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2022 - Explanation of/Insight into the IMDRF documents -" for officials from overseas regulatory authorities who are engaged in the review of medical devices.

 The workshop will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) and will be held on Cisco Systems’ Webex program as an online webinar.

 The webinar is held as the workshop of Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC) Center of Excellence; however, the webinar is open to non-APEC economies as well.

International Medical Device Regulators Forum (IMDRF) and former Global Harmonization Task Force (GHTF) Guidance documents are global standards for medical devices.

 The webinar will cover 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.

 The aims of the webinar are to provide chances for the participants to take a fresh look at their own programs and to gather additional information that may enhance the regulatory systems for medical devices within their own regulatory framework.

Key Webinar Objectives

  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

  • 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 his/her organization is required.

  • ​Attendees who can participate in both of the following time slots.​
  1. Preliminary session

- for internet access confirmation and a brief explanation about the webinar as well as for a team building of the group like self- introduction, etc. to be held at 2:00 P.M. Japan Standard Time (JST) on Monday, November 7.

  1. All of the LIVE sessions

- starting at 2:00 P.M. (JST) during the webinar period of November 14 to November 16.

Other Points to Note

  • The training will be provided in English (with consecutive translation (Japanese-English) in some sessions).
  • All participants should take the PMDA-ATC E-learning Course (Medical Devices Review) (takes about 107 minutes in total) before attending the live sessions.

Date / Time

<Preliminary Session>

  • November 7 (Mon), 2022 2:00 P.M. -3:00 P.M. JST (UTC+9)

<Live Webinar>

  • November 14 (Mon), 2022 2:00 P.M. -4:40 P.M. JST (UTC+9)
  • November 15 (Tue), 2022 2:00 P.M. -4:40 P.M. JST (UTC+9)
  • November 16 (Wed), 2022 2:00 P.M. -4:50 P.M. JST (UTC+9)

Program (subject to change)

See the program

Application (Registration closed)

Number of participants: approx. 30
Close of registration application: September 12, 2022

In order to attend the webinar, please be sure to submit both of the following applications.

  1. ​PMDA-ATC Medical Devices Webinar 2022 - Explanation of/Insight into IMDRF documents
    • To attend the webinar, 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.  If the number of applications exceeds the maximum capacity, selection of the participants will take place at the discretion of PMDA.
    • Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/md2022_coews
    • Confirmation of the registration and additional information on the webinar will be sent to the approved participants after closing the application.
  2. PMDA-ATC E-learning Course (Medical Devices Review)
    • If you have not teken the e-learning course, please use the following link to apply and receive your ID/password. Application webpage: https://www12.webcas.net/form/pub/pmda-atc/e-learning02.
      *All participants are required to complete the e-learning course before attending the webinar.
    • Early submission is recommended. After the closing date, any change or addition of participant(s) may not be accepted.
    • If the number of applications for the webinar exceed the upper limit of 30, PMDA, at its discretion, will select the participants based on the information provided in the application form. The applicants who have completed the PMDA-ATC E-learning Course (Medical Devices Review) may have higher priority in the selection.
    • Confirmation of the registration and additional information will be sent to the approved participants after the close of application.

Fee

  • There is no registration fee for this seminar. 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
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.)

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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