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1st PMDA Medical Devices Training Seminar

Seminar highlights
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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)

Day 1 (Monday, March 3, 2014)

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

 

Day 2 (Tuesday, March 4, 2014)

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

 

Day 3 (Wednesday, March 5, 2014)

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)

 

Day 4 (Thursday, March 6, 2014)

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

 

Day 5 (Friday, March 7, 2014)

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

JCN 3010005007409

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

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