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PMDA-ATC Pharmaceuticals Review Seminar 2018 in Nay Pyi Taw, Myanmar

Introduction

  The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Pharmaceuticals Review Seminar 2018 in Nay Pyi Taw, Myanmar" for officials from regulatory authorities in Myanmar who are engaged in the review of pharmaceuticals.
The Seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) in Nay Pyi Taw, from October 15-16, 2018.
At the Seminar, the details of regulatory review activities for new drugs and generic drugs 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 regulatory system in Myanmar.
The seminar is only for regulators working for Myanmar FDA (not open to those from other countries/regions).
Participation of many regulators from Myanmar is welcomed.
 

Key Seminar Objective

PMDA plans to share the following information.

  1. Basics of regulations and regulatory organization
  2. The key regulatory flow of the product development to post-approval
    - Clinical trials
    - New drug review
    - Generic drug review
  3. To make use of the learnings from case studies and discussions and reflect it back to the participant's work.
 

Who should apply

  • Officials from overseas regulatory authorities in Myanmar who are currently engaged in the review of pharmaceuticals.
  • A basic knowledge of the regulations pertaining to the pharmaceutical product review is required.
  • All participants are expected to actively participate in all of the sessions.
  • The training will be provided in English (with consecutive translation in some sessions).

Duration

October 15-16, 2018.

Program (subject to change)

See attached for the draft program

Registration

Fee

There is no registration fee for this seminar.

Location

TBD

Access

TBD

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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