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PMDA-ATC Pharmaceuticals Review Seminar 2016 in Bangkok, Thailand

Introduction

  The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the 1st overseas seminar, offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC).
  This "PMDA-ATC Pharmaceuticals Review Seminar 2016 in Bangkok, Thailand" will be held on September 26-29, 2016. The seminar is for regulatory authority officials, and is not open to the industry or non-regulatory authorities.
  At the Seminar, the details of PMDA's regulatory works for pharmaceuticals including consultation (scientific advice) and product reviews will be shared, including comparison with the regulations in other countries/regions. In addition, group discussions on the regulatory decision making and discussion session with industry on Multi-Regional Clinical Trial (MRCT) in Asia are planned.
  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.
  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.

          - Clinical Trial Notification, Consultations (Scientific Advice), Product review

          - Newly introduced procedures for the review of innovative products

          - Safety measures (labeling, RMP, MIHARI-Project)

          - Relief services

          - Advanced review with electronic data promotion

  1. To think and discuss about utilization of MRCT in Asia
  2. To obtain an opportunity to discuss how to make regulatory decisions based on specific cases
  3. To make use of the learnings from and the Seminar and consider reflecting
           it back to the regulation in the participant's organization.

Who should apply

  • Officials from the regulatory authorities who are currently engaged in review of pharmaceuticals.

          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

     September 26-29, 2016.

Program (subject to change)

     See attached for the draft program

Registration

  • Registration request should be made by filling in all the necessary items on the application form and sending it by e-mail to PMDA-ATC@pmda.go.jp
  • Registration will close on August 31, 2016.
  • 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 enry to Thailand.
  • 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

Crowne Plaza Bangkok Lumpini Park
952 Rama IV Road, Bangkok 10500 THAILAND
Tel: +66 (0)2 632 9000
Fax: +66 (0)2 632 9011

URL:
http://www.ihg.com/crowneplaza/hotels/us/en/bangkok/bkkcp/hoteldetail

       Nearest Train Station:        MRT Silom or BTS Saladaeng
       Nearest Subway Station:   Sala Daeng BTS station & Silom MRT station

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

JCN 3010005007409

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

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