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Seminar Schedule

Planned Trainings: FY2020 (April 2020 – March 2021)

Given the global impact of COVID-19, seminars will be mainly delivered online this year.

 
No. Contents Date Location  Number of participants
 Report※1
1 Medical Devices Review August 26-27, 2020 Online (for
Thai FDA)
 
2 Quality Control (Herbal Medicine)
(PMDA-ATC Quality Control (Herbal Medicine) Webinar 2020)
September 9-11, 2020 Online  
3 Pediatric Review*1
(PMDA-ATC & U.S. FDA Pediatric Review Webinar 2020)
September 28-October 1, 2020 Online  
4 Medical Devices Review *2
(PMDA-ATC Medical Devices Webinar 2020)
November 16-20, 2020 Online  
5 Pharmaceuticals Review December 14-17, 2020 Online  
6 Multi-Regional Clinical Trial (MRCT)*2 January 18-21, 2021 Online  
7 Pharmacovigilance*2 February 1-4, 2021 Online  

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

※ Once confirmed, information on other seminars will be updated accordingly.
 

Completed Trainings: FY2019 (April 2019 – March 2020)

No. Contents Date Location  Number of participants
 Report※1
1 Pediatric Review*1
(PMDA-ATC & U.S. FDA Pediatric Review Seminar 2019)
July 8-11, 2019 Tokyo (PMDA) 26 from 14 countries/regions/ organization
Report
2 Pharmaceuticals Review*2
(PMDA-ATC & WHO Pharmaceuticals Review Seminar 2019)
July 22-26, 2019 Tokyo (PMDA) and Toyama Prefecture 29 from 19 countries/regions
Report
3 Good Registration Management (GRM) September 17-19, 2019 Taipei, Taiwan 27 from 10 conutries/regions
4 CMC (Chemistry, Manufacturing and Control) / GMP (Good Manufacturing Practice)
(PMDA-ATC CMC/GMP Seminar 2019 Hanoi, Vietnam)
October 9, 2019 Hanoi, Vietnam 33 from Vietnam
Report
5 Good Manufacturing Practice (GMP)
(PMDA-ATC GMP Inspection Seminar 2019)
November 12-15, 2019 Toyama Prefecture 6 from 5 countries/regions
Report
6 Medical Devices Review*3
(PMDA-ATC Medical Devices Seminar 2019)
November 25-29, 2019 Tokyo (PMDA) 29 from 18 countries/regions
Report
7 Quality Control (Herbal Medicine)
(PMDA-ATC Quality Control (Herbal Medicine) Seminar 2019)
December 10-12, 2019 Toyama Prefecture 14 from 13 countries/regions
Report
8 Multi-Regional Clinical Trial (MRCT)*4
(PMDA-ATC MRCT Seminar 2020)
January 20-23, 2020 Tokyo (PMDA) 27 from 14 countries/regions
Report
9 Pharmacovigilance*4
(PMDA-ATC Pharmacovigilance Seminar 2020)
February 3-6, 2020 Tokyo (PMDA) 25 from 15 countries/regions
Report
10 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2020 in Jakarta, Indonesia)
February 13-14, 2020 Jakarta, Indonesia 27 from Indonesia
Report

*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

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 from 12 countries/regions
Report
2 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2018)
June 18-22, 2018 Tokyo (PMDA) and Toyama Prefecture 30 from 16 countries/regions
Report
3 Good Registration Management (GRM) September 26-28, 2018 Taipei, Taiwan 29 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 from Myanmar
Report
5 Quality Control (Herbal Medicine)
(PMDA-ATC Quality Control (Herbal Medicine) Seminar 2018)
October 22-24, 2018 Toyama Prefecture 15 from 14 countries/regions
Report
6 Medical Devices Review
(PMDA-ATC Medical Devices Seminar 2018)
November 12-16, 2018 Tokyo (PMDA) 25 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 from 14 countries/regions
Report
8 Multi-Regional Clinical Trial (MRCT)*3
(PMDA-ATC MRCT Seminar 2019)
January 21-24, 2019 Tokyo (PMDA) 21 from 13 countries/regions
Report
9 Pharmaceuticals Review
(PMDA-ATC Pharmaceuticals Review Seminar 2019 in Jakarta, Indonesia)
January 28-31, 2019 Jakarta, Indonesia 48 from Indonesia
Report
10 Pharmacovigilance*3
(PMDA-ATC Pharmacovigilance Seminar 2019)
February 4-7, 2019 Jakarta, Indonesia 29 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

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

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

 

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Chiyoda-ku, Tokyo 100-0013 Japan

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