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PMDA-ATC Medical Devices Seminar 2017

Introduction

  The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Medical Devices Seminar 2017" for officials from overseas regulatory authorities who are engaged in the review of medical devices and in vitro diagnostics.
  The Seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) at PMDA Office in Tokyo, from November 6 to 10, 2017.
  The Seminar will cover wide range of topics, such as regulations, consultations (scientific advices), product reviews, GCP/GLP/QMS, safety measures, standards, etc. Small group discussions among participants and site visit to a training facility for proper use of advanced medical devices are planned as well.
  The aims of the Seminar are to provide chances for the participants to refer back to their work and to find any additional opportunity for enhancement of the participant's regulatory system.  
  The seminar is not open to the industry or non-regulatory authorities. The seminar is not intended for Japanese government employees, either.
  Participation from many regulatory authorities is welcomed.

Key Seminar Objectives

  1. To learn basics of medical device regulations and regulatory organization
  2. To learn the key regulatory flow of the review of medical devices, especially on the following points.
        - Product classifications based on risk
        - Scientific reviews
        - GCP/GLP/QMS/standards
        - Safety measures
  3. To have discussions among participants using cases to experience the details of the learnings from lectures
  4. To obtain updated information about international medical device activities (utlization of international standards, IMDRF, etc)
  5. To observe the efforts at the training site for proper use of advanced medical devices
  6. To make use of the learnings / findings from the Seminar for the betterment of the regulatory system in the participant’s organization.

Who should apply

  • Medical devices and in vitro diagnostics reviewers from overseas regulatory authorities
  • A basic knowledge of the regulations pertaining to the medical devices product review in his/her organization is required.
        - The training will be provided in English (with simultaneous translation in some sessions).
        - All participants are expected to actively participate in all of the sessions.

Date / Time

November 6 to 10, 2017.

Program (subject to change)

See attached for the draft program

Registration (Registration is closed.)

  • Registration request should be made by filling in all the necessary items on the application form and sending it by e-mail to the e-mail address shown in “Contact Us” below.
  • Registration will close on September 4, 2017.
  • Early registration is recommended. The registration may close before the deadline depending on the number of application. Also, please be sure to allow enough time to obtain the visa for entry to Japan.
  • If the number of applications exceeds the capacity, the number of participants from each country may be limited.
  • Confirmation of the registration and additional meeting information will be sent to the approved participants after the close of registration.

Fee

There is no registration fee for this seminar.
Information on travel and hotel reservation assistance will be announced to the approved participants.

Location

Pharmaceuticals and Medical Devices Agency (PMDA):

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

Access

MAP

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, PMDA Asia Training Center
   E-mail: PMDA-ATC●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

(Note: For the purpose of security, @ in the e-mail addresses are replaced with ●. Please replace ● with @ when you send an e-mail.)

JCN 3010005007409

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

Access/Map

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