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PMDA-ATC & WHO Pharmaceuticals Review Seminar 2019

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC & WHO Pharmaceuticals Review Seminar 2019" for officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals.
The Seminar will be jointly offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) and the World Health Organization (WHO), and will be held in Tokyo at PMDA Office, and in Toyama prefecture for site visit, from July 22-26, 2019.

The Seminar will cover topics relating to product review for new drugs, generic drugs and biosimilars, and efficient review pathways for early access as well, through the lectures and case studies to promote comprehensive understanding of the regulatory systems.

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 participants’ regulatory systems.

The seminar is not open to the industry or non-regulatory authorities.
Participation from many regulatory authorities is welcomed. 

Key Seminar Objective

  1. To learn basics of regulations and regulatory organization
  2. To learn the key regulatory flow of the product development to post-approval
    The Seminar will focus on the following key regulatory activities.
    -Consultations (Scientific Advice)
    -Product review
    -Efficient review pathways for early access
  3. To make use of the learnings from case studies and discussions and reflect it back to the regulatory system in the participant's organization.

Who should apply

  • Employees of regulatory authorities, or other agencies/institutes closely related thereto.
  • Pharmaceutical reviewer with at least 3 years of experience in the review of pharmaceuticals.
  • Basic knowledge of the regulations pertaining to the pharmaceuticals review in his/her organization is required.
Other Points to Note
  • The training will be provided in English (with consecutive translation in some sessions).
  • All participants are expected to actively participate in all of the sessions.
  • There will be a session in which the participant from each country/region gives a brief presentation on the situations of his/her organization with regard to the pharmaceuticals review.

Date

July 22 to 26, 2019

Program (subject to change)

See the draft program (attached)

Registration (Registration is closed)

Number of participants: approx. 30
Close of registration: April 25, 2019.

 
  • Registration request should be made by filling in all the necessary items including signature by the Head of the 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. After the closing date, any change or addition of participant(s) may not be accepted. Please be sure to allow enough time to obtain the visa for entry to Japan, as all the travel arrangements must be fixed before visa application.
  • If the number of applications exceeds the capacity, selection of the participants will take place at the discretion of PMDA based on the information provided in the application form.
  • 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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