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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: FY2019 (April 2019 – March 2020)※1

No. Contents Date Location Number of participants
Report※2
1 Pediatric Review*1
(PMDA-ATC & U.S. FDA Pediatric Review Seminar 2019)
July 8-11, 2019 Tokyo (PMDA)  
2 Pharmaceuticals Review*2
(PMDA-ATC & WHO Pharmaceuticals Review Seminar 2019)
July 22-26, 2019 Tokyo (PMDA)and Toyama Prefecture  
3 Good Registration Management (GRM) September, 2019 Taipei  
4 Good Manufacturing Practice (GMP) November 12-15,
2019
Toyama Prefecture  
5 Medical Devices Review*3 November 25-29, 2019 Tokyo (PMDA)  
6 Quality Control (Herbal Medicine) December 10-12, 2019 Toyama Prefecture  
7 Multi-Regional Clinical Trial (MRCT)*4 January 20-23, 2020 Tokyo (PMDA)  
8 Pharmacovigilance*4 February 3-6, 2020 Tokyo (PMDA)  

*1 Joint Seminar with U.S.FDA, *2 Joint Seminar with WHO, *3 APEC-LSIF-RHSC pilot CoE Workshop, *4 APEC-LSIF-RHSC CoE Workshop
※1Once confirmed, information on other seminars will be updated accordingly
※2Report of the Trainings/Seminars will be posted on the Symposia/Workshop site when it is ready.

Completed Trainings: FY2018 (April 2018 – March 2019)

No. Contents Date Location Number of participants
Report
1 Pediatric Review Seminar*1
(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 29 participants from 11 countries/regions
4 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2018 in Nay Pyi Taw, Myanmar)
October 15-16,
2018
Nay Pyi Taw, Myanmar 32 participants from Myanmar
Report
5 Quality Control (Herbal Medicine)
(PMDA-ATC Quality Control (Herbal Medicine) Seminar 2018)
October 22-24,
2018
Toyama, Toyama Prefecture 15 participants from 14 countries/regions
Report
6 Medical Devices Review
(PMDA-ATC Medical Devices Seminar 2018)
November 12-16,
2018
Tokyo
(PMDA)
25 participants from 17 countries/regions
Report
7 Good Manufacturing Practice (GMP)*2
(PMDA-ATC GMP Inspection Seminar 2018)
November 26-30,
2018
Utsunomiya,
Tochigi
Prefecture
14 participants from 14 countries/regions
Report
8 Multi-Regional Clinical Trial (MRCT)*3
(PMDA-ATC MRCT Seminar 2019)
January 21-24,
2019
Tokyo
(PMDA)
21 participants from 13 countries/regions
Report
9 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2019 in Jakarta, Indonesia)
January 28-31,
2019
Jakarta,
Indonesia
48 participants from Indonesia
Report
10 Pharmacovigilance*3
(PMDA-ATC Pharmacovigilance Seminar 2019)
February 4-7,
2019
Tokyo
(PMDA)
29 participants from 15 countries/regions
Report

*1 Joint Seminar with U.S.FDA, *2 With the support of PIC/S,  *3 APEC-LSIF-RHSC CoE Workshop
Report of the Trainings/Seminars will be posted on the Symposia/Workshop site when it is ready.

Completed Trainings

Completed Trainings

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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