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PMDA-ATC Medical Devices Webinar 2021



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 Medical Devices Webinar 2021" for officials from overseas regulatory authorities who are engaged in the review of medical devices and/or in vitro diagnostics (IVDs).

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.

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.
The webinar will cover wide range of topics, 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 review systems for medical devices and IVDs 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 basics of medical device regulations and the key regulatory flow of the review of medical devices, especially on the following points.
  • Product classifications based on risk level
  • Scientific reviews
  • Safety measures
  1. To obtain up-to-date information about international regulatory harmonization effort for medical devices (utilization of international standards, IMDRF, etc.)
  2. 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 access to “Cisco Webex” and are committed to participating in both the preliminary and the LIVE sessions. The LIVE sessions will start after 2 P.M. Japan Standard Time (JST: UTC+9) during the webinar period via Web browsers. For the system requirement details see the Cisco Webex Help Center.
  • 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.

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 134 minutes in total) before attending the live sessions.

Date / Time

<Preliminary Session>
  • November 8, 2021 2:00 P.M. -3:00 P.M. JST (UTC+9)

<Live Webinar>
  • November 15, 2021 2:00 P.M. -5:00 P.M. JST (UTC+9)
  • November 16, 2021 2:00 P.M. -4:45 P.M. JST (UTC+9)
  • November 17, 2021 2:00 P.M. -4:45 P.M. JST (UTC+9)

Program (subject to change)

See the program (attached)
 

Application

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

  • In order to attend the webinar, please be sure to submit both of the following applications.
  • PMDA-ATC E-learning Course (Medical Devices Review)
    If you have not applied for 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-learning01.
    *All participants are required to complete the e-learning course before attending the webinar.
  • Live Webinar
    You can apply for the Live webinar through the following link: https://www12.webcas.net/form/pub/pmda-atc/medicaldevice2021. Please fill in all the necessary items on the application form, including the signature by the applicant’s supervisor by the closing date.
  • Early submission is recommended. After the closing date, any change or addition of participant(s) may not be accepted.
  • If the number of applications 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

The webinar is free of charge. 
Each participating agency is responsible for obtaining computer access to Cisco Systems’ Webex program (https://www.webex.com/), as well as securing an appropriate environment for each participant (stable internet connection, suitable equipment, etc.)

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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