PMDA-ATC Medical Devices Webinar 2020

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 2020" 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 Webex.

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, consultations (scientific advices), 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 refer back to their work.

The webinar is not open to the industry or non-regulatory authorities. Participation from many regulatory authorities is welcome.

Key Webinar Objective

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

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

• Attendees who can access to “Cisco Webex” and participate in the LIVE sessions starting after 2 P.M. Japan Standard Time (JST) during the webinar period via Web browsers. See attached the system requirements.
• 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 in some sessions)
• All participants are requested to do self-leaning before the LIVE sessions and actively participate in all of the LIVE sessions.

Date / Time

• Pre-LIVE self-learning (viewing videos and e-learning):

          November 9-13, 2020

• LIVE Lectures and Q&A:

          November 16, 2020    13:50 – 15:30 JST  (UTC+9)
          November 17, 2020    14:00 – 15:30 JST  (UTC+9)
          November 18, 2020    14:00 – 16:30 JST  (UTC+9)
          November 19, 2020    14:00 – 16:30 JST  (UTC+9)
          November 20, 2020    14:00 – 16:50 JST  (UTC+9)

Program (subject to change)

See attached the program

Registration (Registration is closed)

Number of participants: approx. 30
Close of registration: September 21, 2020

• Registration requests should be made by filling in all the necessary items including the signature of the applicant’s supervisor on the application form (attached).Please send the form as a Word file (without signature) and a PDF file (with signature) by e-mail to the e-mail address shown in “Contact Us” below.
• Early registration is recommended. After the closing date, any change or addition of participant(s) may not be accepted.
• If there are more applications than available spaces, selection of the participants will take place at the discretion of PMDA based on the information provided in the application form.
• Confirmation of the registration, connection test and additional information will be sent to the accepted participants after the close of registration.

Fee

There is no registration fee for this webinar.

Each participating agency is responsible for obtaining computer access to Cisco’s WebEx program (https://www.webex.com/).

Contact Us

For more information, please contact:

Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC●pmda.go.jp

Office of International Program
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.)