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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: FY2018 (April 2018 – March 2019)

No. Contents Date Location Number of participants
Report
1 Pediatric Review Seminar
(PMDA-ATC & U.S. FDA Pediatric Review Seminar 2018)
June 11-14,
2018
Tokyo
(PMDA)
24 participants from 12 countries/regions
Report
2 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2018)
June 18-22,
2018
Tokyo (PMDA)and Toyama Prefecture 30 participants from 16 countries/regions
Report
3 Good Registration Management (GRM)* September 26-28, 2018 Taipei  
4 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2018 in Nay Pyi Taw, Myanmar)
October 15-16,
2018
Nay Pyi Taw, Myanmar  
5 Quality Control (Herbal Medicine)
(PMDA-ATC Quality Control (Herbal Medicine) Seminar 2018)
October 22-24,
2018
Toyama, Toyama Prefecture  
6 Medical Devices Review
(PMDA-ATC Medical Devices Seminar 2018)
November 12-16,
2018
Tokyo
(PMDA)
 
7 Good Manufacturing Practice (GMP)
(PMDA-ATC GMP Inspection Seminar 2018)
November 26-30,
2018
Utsunomiya,
Tochigi
Prefecture
 
8 Multi-Regional Clinical Trial (MRCT)* January 21-24,
2019
Tokyo
(PMDA)
 
9 Pharmaceuticals Review January 28-31,
2019
Jakarta,
Indonesia
 
10 Pharmacovigilance* February 4-7,
2019
Tokyo
(PMDA)
 

*APEC-LSIF-RHSC CoE Workshop
※Report of the Trainings/Seminars will be posted on the Symposia/Workshop site when it is ready.

Completed 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,
Indonesia
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 countries/regions
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 countries/regions
Report
4 Pharmaceuticals
(PMDA-ATC Parmaceuticals Seminar 2017 in Hanoi, Vietnam)
Oct. 3-4,
2017
Hanoi,
Vietnam
30 participants from Vietnam
Report
5 Medical Devices
(PMDA-ATC Medical Devices Seminar 2017)
Nov. 6-10,
2017
Tokyo
(PMDA)
30 participants from 12 countries/regions
Report
6 Good Registration Management (GRM)* Oct. 31-Nov. 2,
2017
Taipei 30 participants from 8 countries/regions
7 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2017 in Bangkok, Thailand)
Dec. 12-15,
2017
Bangkok,
Thailand
20 participants from Sri Lanka and Thailand
Report
8 Multi-Regional Clinical Trial (MRCT)*
(PMDA-ATC MRCT Seminar 2018)
Jan. 15-18,
2018
Tokyo
(PMDA)
25 participants from 11 countries/regions
Report
9 Pharmacovigilance*
(PMDA-ATC Pharmacovigilance Seminar 2018)
Feb. 5-8,
2018
Tokyo
(PMDA)
29 participants from 17 countries/regions
Report

*APEC-LSIF-RHSC CoE Workshop
※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 countries/regions
Report
2 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2016 in Bangkok, Thailand)
Sep. 26-29,
2016
Bangkok,
Thailand
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 countries/regions
Report
4 Good Registration Management Nov. 15-17,
2016
Taipei 28 participants from 10 countries/regions
5 GMP (Good Manufacturing Practice)
(PMDA-ATC GMP Inspection Seminar 2016)
Dec. 5-9,
2016
Toyama City,
Toyama Prefecture
19 participants from 12 countries/regions
Report
6 Multi-Regional Clinical Trial
(PMDA-ATC MRCT Seminar 2017)
Jan. 23-26,
2017
Tokyo
(PMDA)
32 participants from 14 countries/regions
Report
7 Pharmacovigilance
(PMDA-ATC Pharmacovigilance Seminar 2017)
Feb. 6-9,
2017
Tokyo
(PMDA)
28 participants from 15 countries/regions
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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