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PMDA-ATC Medical Devices Seminar 2018

Introduction

 The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Medical Devices Seminar 2018" 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 12 to 16, 2018.
   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 manufacturing facilities 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. 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 (utilization of international standards, IMDRF, etc)
  5. To observe the efforts at the manufacturing site to comply with the regulation
  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

  • Officials from regulatory authorities who are currently engaged in review of medical devices and in-vitro diagnostics.
  • 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.
  • A participant from each country/ region should present his/her review systems of medical devices in his/her country/region to other participants.

Date / Time

November 12 to 16, 2018.

Program (subject to change)

See attached for the draft program

Registration

Number of participants: approx. 30
Close of registration: August 31, 2018.

  • Registration request should be made by filling in all the necessary items including signature by Head of Organization on the application form (attached).  Please send the form in both the Word file (without signature) and the PDF file (with signature) by e-mail to the e-mail address shown in “Contact Us” below.
  • Early registration is recommended. 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 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, Namboku 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

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