Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Pharmaceuticals CMC/GMP Seminar 2019 in Hanoi, Vietnam" for officials from regulatory authorities in Vietnam who are engaged in the review of pharmaceuticals and GMP inspection.
The Seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), on October 9, 2019.
At the seminar, the details of regulatory review of Chemistry, Manufacturing and Control (CMC) and GMP inspection through the lecture and case study. The aims of the seminar are to provide the participants to refer back to their work and to find any additional opportunity for enhancement of the regulatory system in Vietnam.
The seminar is only for regulators and GMP inspectors working for The Drug Administration Department of Vietnam (DAV), not open to those from other countries/regions.
Participation of many Vietnamese regulators and GMP inspectors is expected.
Key seminar objective
- To learn the key regulatory review of CMC
- To acquire and level up skills on how to make risk-based decisions during GMP inspection
- To make use of the awareness from case studies and discussions and utilize them to participant's work
Who should apply
- Officials from DAV who are currently engaged in the review of pharmaceuticals and GMP inspection.
- A basic knowledge of the regulations pertaining to the pharmaceutical product review and GMP inspection 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
October 9, 2019Program
Registration
- Registration will be internally gathered by DAV
- 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 September 30, 2019.
Fee
There is no registration fee for this seminar.
Location
Pullman Hanoi Hotel
40 Cat Linh street, Dong Da district, 10000 Hanoi Vietnam
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.)