- 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:
- General descriptions of PMDA's role in regulation
- General descriptions of Japanese medical device regulations
- General descriptions of review of medical devices, including case studies
- Scientific review
- Clinical trials
- QMS inspection
- Safety measures
- 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