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) at Park Royal Hotel 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.
- Basics of regulations and regulatory organization
- The key regulatory flow of the product development to post-approval
- Clinical trials
- New drug review
- Generic drug review - 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 (Registration is closed.)
- Registration will be internally gathered by Myanmar FDA.
- 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 was closed on July 23, 2018.
Fee
There is no registration fee for this seminar.
Location
PARKROYAL Hotel Nay Pyi Taw
Jade Villa No. 13/14, Hotel Zone, Dekhina Thiri Tsp, Nay Pyi Taw, Myanmar
Telephone +95 67 810 6088
Fax +95 67 810 6068
Email enquiry. prnyt@parkroyalhotels.com
Access
Junction Nay Pyi Taw Shopping Center 10 minutes' drive
Water Fountain Garden 12 minutes' drive
Distance to Airport 40 minutes’ drive
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.)