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PMDA-ATC Pharmaceuticals Review Seminar 2017 in Bangkok, Thailand

Introduction

  The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the overseas seminar entitled, “PMDA-ATC Pharmaceuticals Review Seminar 2017," for new drug application reviewers from overseas regulatory authorities.
  The overseas Seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) in Bangkok, Thailand on December 12-15, 2017.
  At the Seminar, the details of regulatory activities for pharmaceuticals including consultation and product reviews will be shared.  Case studies and discussions among participants 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 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
  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

  • New drug application reviewers from overseas regulatory authorities
  • A basic knowledge of the regulations pertaining to the pharmaceutical product review in his/her organization is required.
      - 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.

Date / Time

December 12-15, 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 8, 2017.
  • Early registration is recommended. The registration may close before the deadline depending on the number of application.
  • 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.
Attendees are responsible for their own travel, accommodation and food expenses.
Hotel discounts available for participants. Reservation information will be announced to the approved participants.

Location

Holiday Inn Bangkok Sukhumvit
1 Sukhumvit 22, Klongton, Klongtoey, Bangkok 10110 Thailand
Tel: +66 (0)2 683 4888
Fax: +66 (0)2 683 4777

URL:
https://www.ihg.com/holidayinn/hotels/gb/en/bangkok/bkkhi/hoteldetail
 

Nearest SkyTrain Station:        BTS Asok or BTS Phrom Phong
Nearest Subway Station:          MRT Sukhumvit station

Access

MAP (Click to enlarge.)
MAP

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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