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Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs
On the basis of "PMDA International Strategic Plan 2015", published in June 2015 by PMDA, "Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC)" was newly established on April 1, 2016.
This Training Center will provide the training for regulators in Asia in response to the demands made by them by making use of the accumulated knowledge and experiences of PMDA. The content of the training will include basic lectures on information necessary to build regulatory capacity in each country/region, such as benefit/risk evaluation of the medical products and post-marketing safety measures.
Besides, the Center will provide the programs such as on-site mock inspection in cooperation with actual manufacturing facilities.
Annoucement of the Trainings/Seminars will be posted on the Symposia/Workshop site.
PMDA will, through the Center, contribute to enhancement and mutual understanding of regulations, and strengthening of cooperation in Asia and other parts of the world.
Planned Trainings: FY2017 (April 2017 – March 2018)
| No. | Contents | Date | Location | Number of participants Report※ |
| 1 | Risk Management Plan (RMP) (PMDA-ATC RMP Seminar 2017 in Jakarta, Indonesia) |
May 18-19, 2017 |
Jakarta | |
| 2 | Pharmaceuticals Review (PMDA-ATC Pharmaceuticals Review Seminar 2017) |
June 26-30, 2017 |
Tokyo (PMDA)and Toyama Prefecture | |
| 3 | Good Manufacturing Practice (GMP) (PMDA-ATC GMP Inspection Seminar 2017) |
July 31- Aug. 4 2017 |
Hikari City, Yamaguchi Prefecture |
|
| 4 | Anti-infective | Oct., 2017 (TBD) |
Vietnam (TBD) |
|
| 5 | Medical Devices | Nov., 2017 (TBD) |
Tokyo (PMDA) |
|
| 6 | Good Registration Management (GRM) | Nov., 2017 (TBD) |
Taipei | |
| 7 | Pharmaceuticals Review | Dec., 2017 (TBD) |
Bangkok | |
| 8 | Multi-Regional Cinical Trial (MRCT) | Jan., 2018 (TBD) |
Tokyo (PMDA) |
|
| 9 | Pharmacovigilance | Feb., 2018 (TBD) |
Tokyo (PMDA) |
※Report of the Trainings/Seminars will be posted on the Symposia/Workshop site when it is ready.
Completed Trainings: FY2016 (April 2016 – March 2017)
| No. | Contens | Date | Location | Number of participants Reports※ |
| 1 | Pharmaceuticals Review (PMDA-ATC Pharmaceuticals Review Seminar 2016) |
July 25-29, 2016 |
Tokyo (PMDA) |
13 participants from 7 economies Report |
| 2 | Pharmaceuticals Review (PMDA-ATC Pharmaceuticals Review Seminar 2016 in Bangkok, Thailand) |
Sep. 26-29, 2016 |
Bangkok | 13 participants from Thailand and Hong Kong |
| 3 | Medical Devices (PMDA-ATC Medical Devices Seminar 2016) |
Nov. 7-11, 2016 |
Tokyo (PMDA) |
28 participants from 13 economies Report |
| 4 | Good Registration Management | Nov. 15-17, 2016 |
Taipei | 28 participants from 10 economies |
| 5 | GMP (Good Manufacturing Practice) (PMDA-ATC GMP Inspection Seminar 2016) |
Dec. 5-9, 2016 |
Toyama City, Toyama Prefecture |
19 participants from 12 economies Report |
| 6 | Multi-Regional Clinical Trial (PMDA-ATC MRCT Seminar 2017) |
Jan. 23-26, 2017 |
Tokyo (PMDA) |
32 participants from 14 economies Report |
| 7 | Pharmacovigilance (PMDA-ATC Pharmacovigilance Seminar 2017) |
Feb. 6-9, 2017 |
Tokyo (PMDA) |
28 participants from 15 economies Report |
※Report of the Trainings/Seminars will be posted on the Symposia/Workshop site when it is ready.
