Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Pharmaceuticals Seminar 2017 in Hanoi, Vietnam" for officials from regulatory authorities in Vietnam 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) at Hanoi Hotel, Hanoi, from October 3 to 4, 2017.
At the Seminar, the details of regulatory activities for pharmaceuticals including clinical trials, product application review, GCP/GLP, and post-marketing safety measures 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 Vietnam.
The seminar is only for regulators working for Drug Administration of Vietnam (DAV) (not open to those from other countries/regions).
Participation of many Vietnamese regulators is expected.
Key Seminar Objective
PMDA plans to share the following information.
- Basics of regulations and regulatory organization
- The key regulatory flow of the product development to post-approval
- Clinical trials
- Product application review
- GCP/GLP
- Post-marketing safety measures - To make use of the awareness from case studies and discussions and utilize them to participant's work.
Who should apply
- Officials from regulatory authorities in Vietnam 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 / Time
October 3-4, 2017
Program (subject to change)
See attached draft program.
Registration
Registration will be internally gathered by DAV.
Fee
There is no registration fee for this seminar.
Location
Hanoi Hotel
D8 Giang Vo, Ba Dinh District, Hanoi, Vietnam 10000
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
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