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
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
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 |