PMDA-ATC Medical Devices Webinar 2022 - Implementation and Adaptation of IMDRF documents in the Japanese Medical Device Regulations -

 

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Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Medical Devices Webinar 2022 - Implementation and Adaptation of Japanese Medical Device Regulation based on GHTF/IMDRF documents -" for officials from overseas regulatory authorities who are engaged in the review of medical devices.
The webinar 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.
International Medical Device Regulators Forum (IMDRF) and former Global Harmonization Task Force (GHTF) Guidance documents are global standards for medical devices.

The webinar is held as independent workshop by PMDA and NOT a Center of Excellence workshop following the core curriculum of the APEC-LSIF-RHSC Medical Devices Priority Work Area (PWA).

The webinar will cover implementation and adaptation of Japanese medical device regulation based on GHTF/IMDRF documents, such as IVD, AI-based medical devices, review of high risk medical devices, Software as a Medical Device (SaMD), 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 on practical application of international standards that may enhance the regulatory systems for medical devices within their own regulatory framework.
The webinar is not open to the industry or non-regulatory authorities. Participation from many regulatory authorities is welcome.

Key Webinar Objectives

1. To learn regulations of specific medical devices, especially in the following fields.
   • IVD medical devices
   • AI-based medical devices
   • High risk (Classes C and D) medical devices
   • Software as a Medical Device (SaMD)
2. To obtain up-to-date information about some specific medical devices of high interest.
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

• 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 21.
  2. All of the LIVE sessions
     - starting at 2:00 P.M. (JST) during the webinar period of November 28 to November 30.

Other Points to Note

• The training will be provided in English (with English-Japanease consecutive translation)
• All participants should take the PMDA-ATC E-learning Course (Medical Devices Review) (takes about 107 minutes in total) before attending the live sessions.
• All sessions will be conducted using the Cisco Webex Meeting system.
• Please confirm the attached system requirements.

Date / Time

<Preliminaly session>

• November 21 (Mon), 2022 2:00 P.M. -3:00 P.M. JST (UTC+9)

<LIVE Lectures and Q&A>

• November 28 (Mon), 2022 2:00 P.M. -4:40 P.M. JST (UTC+9)
• November 29 (Tue), 2022 2:00 P.M. -4:40 P.M. JST (UTC+9)
• November 30 (Wed), 2022 2:00 P.M. -4:50 P.M. JST (UTC+9)

Program (subject to change)

See the program (attached)

Application　(Registration closed)

Number of participants: approx. 30
Close of registration application : September 26, 2022

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

1. PMDA-ATC Medical Devices Webinar 2022 - Implementation and Adaptation of Japanese Medical Device Regulation based on GHTF/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_pmdaws
   • 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.)