Introduction
The pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Pharmaceuticals Review Seminar 2020 in Jakarta, Indonesia” for officials from regulatory authorities in Indonesia who are engaged in the review of pharmaceuticals, from February 13 to 14, 2020.
The seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), with cooperation by Japan International Cooperation Agency (JICA) and National Agency of Drug and Food Control (NA-DFC).
The Seminar will cover a wide range of topics including review for new drugs and generic drugs, Chemistry, Manufacturing and Control (CMC) review and clinical review through the lectures and case studies, 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 NA-DFC, not open to those from other countries/regions.
Participation of many Indonesian regulators is expected.
Key Seminar Objective
- To learn the key pharmaceutical review flow
- Review for new drugs and generic drugs
- Chemistry, Manufacturing and Control (CMC) review
- Clinical review
- Review pathway for innovative drugs
- 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 NA-DFC 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
February 13-14, 2020
Program (subject to change)
See attached draft program.(attached)
Registration (Registration is closed)
- Registration will be internally gathered by NA-DFC.
- 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 January 20, 2020.
Fee
There is no registration fee for this seminar.
Location
Hotel Gran Melia Jakarta
Jl. H. R. Rasuna Said No.Kavling 10. Jakarta Selatan Contact: Ms. Nuris Amalianti
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.)