The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the 1st overseas seminar, offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC).
This "PMDA-ATC Pharmaceuticals Review Seminar 2016 in Bangkok, Thailand" will be held on September 26-29, 2016. The seminar is for regulatory authority officials, and is not open to the industry or non-regulatory authorities.
At the Seminar, the details of PMDA's regulatory works for pharmaceuticals including consultation (scientific advice) and product reviews will be shared, including comparison with the regulations in other countries/regions. In addition, group discussions on the regulatory decision making and discussion session with industry on Multi-Regional Clinical Trial (MRCT) in Asia are planned.
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 participant's regulatory system.
Participation from many regulatory authorities is welcomed.
- Clinical Trial Notification, Consultations (Scientific Advice), Product review
- Newly introduced procedures for the review of innovative products
- Safety measures (labeling, RMP, MIHARI-Project)
- Relief services
- Advanced review with electronic data promotion
A basic knowledge of the regulations pertaining to the pharmaceutical product review in
his/her organization 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.
September 26-29, 2016.
See attached for the draft program
There is no registration fee for this seminar.
Attendees are responsible for their own travel, accommodation and food expenses.
Hotel discounts available for participants. Reservation information will be announced to the approved participants.
Crowne Plaza Bangkok Lumpini Park
952 Rama IV Road, Bangkok 10500 THAILAND
Tel: +66 (0)2 632 9000
Fax: +66 (0)2 632 9011
Nearest Train Station: MRT Silom or BTS Saladaeng
Nearest Subway Station: Sala Daeng BTS station & Silom MRT station
For more information, please contact:
Secretariat, PMDA Asia Training Center
Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan