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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.
 

Asia Training Center image

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 30 participants from Indonesia
Report
2 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2017)
June 26-30,
2017
Tokyo (PMDA)and Toyama Prefecture 28 participants from 11 economies
Report
3 Good Manufacturing Practice (GMP)
(PMDA-ATC GMP Inspection Seminar 2017)
July 31- Aug. 4,
2017
Hikari City,
Yamaguchi Prefecture
13 participants from 13 economies
Report
4 Pharmaceuticals
(PMDA-ATC Parmaceuticals Seminar 2017 in Hanoi, Vietnam)
Oct. 3-4,
2017
Hanoi 30 participants from Vietnam
Report
5 Medical Devices
(PMDA-ATC Medical Devices Seminar 2017)
Nov. 6-10,
2017
Tokyo
(PMDA)
 
6 Good Registration Management (GRM) Nov.,
2017 (TBD)
Taipei  
7 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2017 in Bangkok, Thailand)
Dec. 12-15,
2017
Bangkok  
8 Multi-Regional Cinical Trial (MRCT)
(PMDA-ATC MRCT Seminar 2018)
Jan. 15-18,
2018
Tokyo
(PMDA)
 
9 Pharmacovigilance
(PMDA-ATC Pharmacovigilance Seminar 2018)
Feb. 5-8,
2018
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. Contents 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.

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

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Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs
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