3rd PMDA Medical Devices Training Seminar

• Introduction
• Eligible Participants
• Date / Time
• Program Agenda
• Registration
• Fee
• Location
• Access
• Contact Us

 

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "3rd PMDA Medical Devices Training Seminar" for international regulatory authorities scheduled for February 15-19, 2016. The PMDA Medical Devices Training Seminar is established for the exchange of medical device regulatory information between the PMDA and its counterpart agencies all over the world. The seminar is not open to the medical device industry or non-regulatory authorities. The seminar is not intended for Japanese government employees, either.

 

The 3rd PMDA Medical Devices Training Seminar is designed for officials who are engaged in the review of medical devices and in vitro diagnostics.

PMDA experts will present the following:

1. General descriptions of PMDA's role in regulation
2. General descriptions of Japanese medical device regulations
3. General descriptions of review of medical devices, including case studies

• Scientific review
• Clinical trials
• QMS inspection
• Safety measures

4. Site tour (manufacturer's training facility)

The training will be provided in English. All participants are expected to actively participate in all of the sessions.

Eligible Participants

Participation in the PMDA Medical Devices Training Seminar is limited to officials who are engaged in review of medical devices and in vitro diagnostics. Confirmation of registration and additional meeting information will be sent to the approved participants.

Date / Time

February 15 to 19, 2016, 10:00 a.m. to 5:30 p.m. (Day 4 start/end time may vary)

Program (subject to change)

Day 1 (Monday, February 15, 2016)

10:00 - 10:15	Welcome speech
10:15 - 10:30	Overview of Training Program/Schedule
10:30 - 11:00	Overview of PMDA (organization and functions)
11:00 - 12:00	Overview of Medical Device Regulations
12:00 - 13:00	Lunch Break
13:00 - 15:00	Review and Approval of Medical Devices (definition, classification, review process, scientific advices, etc)
15:00 - 15:30	Break
15:30 - 16:00	GCP/GLP inspections
16:00 - 17:30	Clinical Trials for Medical Devices

 

Day 2 (Tuesday, February 16, 2016)

10:00 - 11:00	Quality Management for Medical Devices
11:00 - 12:00	Post‐marketing Safety Measures for Medical Devices
12:00 - 13:00	Lunch Break
13:00 - 14:00	Utilization of International Standards
14:00 - 15:00	Third‐party Certification (by registered certification body)
15:00 - 15:30	Break
15:30 - 17:30	Introduction of Medical Device Regulations of Participant's Own Country (by participants)

 

Day 3 (Wednesday, February 17, 2016)

10:00 - 12:00	Industry-Government-Academia collaboration (discussion on strategic consultation, collaboration, etc with experts from academia and industry)
12:00 - 13:00	Lunch Break
13:00 - 14:00	Review and Approval of Medical Devices (combination products, etc)
14:00 - 15:00	Review and Approval of IVD
15:00 - 15:30	Break
15:30 - 17:30	Group work on Review of Medical Devices #1

 

Day 4 (Thursday, February 18, 2016)

10:00 - 17:30

Site Tour (manufacturer’s training facility)

 

Day 5 (Friday, February 19, 2016)

10:00 - 12:00	Group work on Review of Medical Devices #2
12:00 - 13:00	Lunch Break
13:00 - 15:00	International Activities on Medical Devices Regulation (IMDRF guidelines, etc)
15:00 - 15:30	Break
15:30 - 16:00	Wrap up
16:00 - 16:30	Closing remarks, Presentation of certificates

 

Registration

Registration has closed on January 12, 2016.

Fee

There is no registration fee for this seminar.
Attendees are responsible for their own travel, accommodation and food expenses.

Location

Pharmaceuticals and Medical Devices Agency (PMDA):

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

Access

Please use public transportation. Nearest Tokyo Metro Subway Stations:

• 5 minutes walk from Exit 11 of Toranomon Station on the Ginza Line
• 8 minutes walk from Exit 3 of Kokkai-gijido-mae Station, on the Marunouchi Line, Chiyoda Line
• 8 minutes walk from Exit A13 of Kasumigaseki Station, on the Marunouchi Line, Chiyoda Line, Hibiya Line
• 10 minutes walk from Exit 8 of Tameike-sanno Station, on the Ginza Line, Nanboku Line

Contact Us

For more information, please contact:

Secretariat, Medical Devices Training Seminar
E-mail: PMDA-MD-training@pmda.go.jp

Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
 

>Click here for the report of the seminar