Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce its first PMDA Medical Devices Training Seminar for International Regulatory Authorities scheduled for March 3-7, 2014. The PMDA training seminars are established for the exchange of drug and medical device regulatory information between the PMDA and its counterpart agencies all over the world. The training is not open to the pharmaceutical industry or non-regulatory authorities. The training is not intended for Japanese government employees.
The 1st PMDA Medical Devices Training Seminar is designed for officials who are engaged in 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 pharmaceutical regulations
3) General descriptions of review of medical devices, their case studies
- Scientific review
- Clinical trials
- QMS inspection
- Safety measures
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
March 3 to 7, 2014, 10:00 a.m. to 5:30 p.m.
Program Agenda (subject to change)
| 10:00 - 10:10 | Welcome speech |
|---|---|
| 10:10 - 11:00 | Overview of Training Program/Schedule Overview of PMDA (organization and functions) |
| 11:00 - 12:00 | Pharmaceutical Affairs Law - Overview, review/approval |
| 12:00 - 13:00 | Lunch Break |
| 13:00 - 15:00 | Pharmaceutical Affairs Law - Liabilities of manufacturers, distributors, etc. - International trend on regulations for medical devices |
| 15:00 - 15:30 | Break |
| 15:30 - 17:00 | Abstract of medical devices review |
| 10:00 - 12:00 | QMS for medical devices |
|---|---|
| 12:00 - 13:00 | Lunch Break |
| 13:00 - 14:00 | Clinical trial for medical devices |
| 14:00 - 15:00 | Quality assurance for medical devices |
| 15:00 - 15:30 | Break |
| 15:30 - 17:30 | Safety measures for medical devices |
| 10:00 - 11:00 | Review of in vitro diagnostics |
|---|---|
| 11:00 - 12:00 | Approval/certification criteria for medical devices |
| 12:00 - 13:00 | Lunch Break |
| 13:00 - 14:00 | Key points for medical devices review (electric safety) - Electric safety in general - Electromagnetic compatibility |
| 14:00 - 15:00 | Key points for medical devices review - Biological safety - Biodegradable material |
| 15:00 - 15:30 | Break |
| 15:30 - 16:30 | Regulatory science |
| 16:30 - 17:30 | Explanation on Opinion Exchange Session on Day 5 (regulations of each participant's country) |
| 10:00 - 12:00 | Case study (1) |
|---|---|
| 12:00 - 13:00 | Lunch Break |
| 13:00 - 15:00 | Case study (2) |
| 15:00 - 15:30 | Break |
| 15:30 - 17:30 | Preparation for presentations on Day 5 |
| 10:00 - 12:00 | Case study (3) |
|---|---|
| 12:00 - 13:00 | Lunch Break |
| 13:00 - 15:00 | Introduction of regulations of participant's own country (to be presented by participants)/Opinion exchange |
| 15:00 - 15:30 | Break |
| 15:30 - 17:30 | Wrap up |
Location
Pharmaceuticals and Medical Devices Agency (PMDA):
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku,Tokyo 100-0013, Japan