- 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 second PMDA Medical Devices Training Seminar for International Regulatory Authorities scheduled for February 2-6, 2015. 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 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
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, their case studies
- Scientific review
- Clinical trials
- QMS inspection
- Safety measures
A one-day manufacturing site tour will be also arranged during the seminar.
The training will be conducted in English. All participants are expected to actively participate in all of the sessions.
Eligible Participants
Participation in the PMDA MD 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 2 to 6, 2015, 10:00 a.m. to 5:30 p.m. (7:00 a.m. to 6:00 p.m. for the factory tour)
Program (subject to change)
Day 1 (Monday, February 2, 2015)
| 10:00 - 10:10 | Welcome speech |
|---|---|
| 10:10 - 10:20 | Overview of Training Program/Schedule |
| 10:20 - 12:00 | Overview of PMDA (organization and functions) Overview of medical device regulations |
| 12:00 - 13:00 | Lunch Break |
| 13:00 - 15:00 | Overview of PMD Act (Revised Pharmaceutical Affairs Law) - Outlines - Major differences |
| 15:00 - 15:30 | Break |
| 15:30 - 16:30 | Abstract of medical devices review |
Day 2 (Tuesday, February 3, 2015)
| 10:00 - 12:00 | Introduction of medical device regulations of participant's own country (1) (by participants) |
|---|---|
| 12:00 - 13:00 | Lunch Break |
| 13:00 - 15:00 | Introduction of medical device regulations of participant's own country (2) (by participants) |
| 15:00 - 15:30 | Break |
| 15:30 - 17:30 | Case study (1) |
Day 3 (Wednesday, February 4, 2015)
| 10:00 - 12:00 | Case study (2) |
|---|---|
| 12:00 - 13:00 | Lunch Break |
| 13:00 - 15:00 | Third-party certification (by registered certification body) |
| 15:00 - 15:30 | Break |
| 15:30 - 17:30 | Quality management for medical devices Actuality of QMS inspection |
Day 4 (Thursday, February 5, 2015)
| 7:00 - 18:00 | Manufacturing site tour |
|---|
Day 5 (Friday, February 6, 2015)
| 10:00 - 12:00 | GCP Clinical trials for medical devices |
|---|---|
| 12:00 - 13:00 | Lunch Break |
| 13:00 - 15:00 | Post-marketing safety measures for medical devices |
| 15:00 - 15:30 | Break |
| 15:30 - 16:00 | Wrap up |
| 16:00 - 16:30 | Closing remarks, Presentation of certificates |
Registration
Registration request should be made by submitting the completed application form:
The application form is in Word / PDF format. Please download here. "Application form", "Application form"
Please fill in all the necessary items on the application form and send it by e-mail to PMDA-MD-training@pmda.go.jp
Registration will close on December 31, 2014. We recommend you to register early, as we may need to close the registration before the deadline, if we receive more applications than our capacity. Also, please be sure to allow enough time to obtain your visa.
Fee
This program is free of charge.
However, attendees are responsible for their own travel, lodging 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 Programs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan