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PMDA-ATC Pharmaceuticals Review Seminar 2019 in Jakarta, Indonesia

Introduction

  The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Pharmaceuticals Review Seminar 2019 in Jakarta, Indonesia" for officials from regulatory authorities in Indonesia 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), with Japan International Cooperation Agency (JICA) as the co-host, from January 28 to 31, 2019.

  The Seminar will cover a wide range of topics including product review for not only new drugs but also generic drugs and biosimilars, CMC, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), etc. through the lecture and case study, aiming to provide the participants with opportunities to acquire knowledge and perspectives to enhance the regulatory system in Indonesia.

  The seminar is only for regulators working for National Agency of Drug and Food Control (NADFC), not open to those from other countries/regions.
  Participation of many Indonesian regulators is expected.
 

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
  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

  • Officials from NADFC who are currently engaged in the review of pharmaceuticals.
  • A basic knowledge of the regulations pertaining to the pharmaceutical product review 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

January 28-31, 2019

Program (subject to change)

See attached draft program.

Registration

  • Registration will be internally gathered by NADFC.
  • 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 PMDA-ATC●pmda.go.jp
  • Registration will close on November 30, 2018.

Fee

There is no registration fee for this seminar.

Location

National Agency of Drug and Food Control (NADFC)
Jl. Percetakan Negara No.23 - Jakarta 10560 Indonesia

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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