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Seminar Schedule
Planned Trainings: FY2022 (April 2022 – March 2023)
Given the global impact of COVID-19, the seminars in this fiscal year will be delivered online.
1. Seminars (open to all regulators)
| No. | Contents | Date | Location | Number of participants Report※1 |
|---|---|---|---|---|
| 1 | Quality Control (Herbal Medicine) (PMDA-ATC Quality Control (Herbal Medicine) Webinar 2022) |
August 23-25, 2022 | Online | 25 from 17 countries/regions Report |
| 2 | Pediatric Review*1 (PMDA-ATC & U.S. FDA Pediatric Review Webinar 2022) |
September 12-15, 2022 | Online | 28 from 11 countries/regions Report |
| 3 | Good Registration Management (GRM)(External site / 2022 APEC GRM CoE WORKSHOP) | September 13 | Online | 54 from 8 countries/regions |
| 4 | Good Manufacturing Practice (GMP)(PMDA-ATC GMP inspection Webinar 2022) | October 25-26, 2022 | Online | 25 from 19 countries/regions Report |
| 5 | Medical Devices Review*2 (APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2022) |
November 14-16, 2022 | Online | |
| 6 | Medical Devices Review (PMDA-ATC Medical Devices Webinar 2022) |
November 28-30, 2022 | Online | |
| 7 | Pharmaceuticals Review (PMDA-ATC Pharmaceuticals Review Webinar 2022) |
December 6-8, 2022 | Online | |
| 8 | Multi-Regional Clinical Trial (MRCT)*2,*3 (PMDA-ATC with National Cancer Center MRCT Webinar 2022) |
January 16-19, 2023 | Online | |
| 9 | Pharmacovigilance*2 (PMDA-ATC Pharmacovigilance Webinar 2023) |
February 6-9, 2023 |
Online |
*1 Joint Seminar with U.S.FDA, *2 APEC-LSIF-RHSC CoE Workshop, *3 Collaboration with National Cancer Center Japan
2. Other Seminars (for specific members)
| No. | Contents | Date | Location | Number of participants Report※1 |
|---|---|---|---|---|
| 1 | Risk Management Plan(RMP) | May 24-25, 2022 | Online (for ASEAN PPWG members) | 28 from 10 countries/regions |
| 2 | Good Registration Management (GRM) | June 22, 2022 | Online (for CDSCO, India) | 40 |
| 3 | Pharmaceuticals Review | July 13-15 and 19, 2022 | Online (for JICA *1 trainees) | 8 from 7 countries/regions Report |
| 4 | GCTP（Good Gene, Cellular, and Tissue-based Products Manufacturing Practice） | Sep 14-16, 2022 | (for NPRA Malaysia) | 2 |
| 5 | First in Human | Sep 26-30, 2022 | Tokyo (PMDA) (for NPRA Malaysia) |
2 |
| 6 | COVID-19 Vaccine Review | October 24,2022 | Hybrid (for Indonesian FDA) | approx 80 Report |
| 7 | Medical Devices Review (PMDA-ATC/AMDC Medical Devices Webinar 2022) | October 28, 2022 | Online (for AMDC member states) |
38 from 8 countries/regions |
| 8 | PV (Pharmacovigilance) | November 21, 2022 | Online (for FDA Philippines) |
|
| 9 | GCP inspection in MRCT | December 6, 2022 | Online (for FDA Philippines) |
*1 JICA : Japan International Cooperation Agency
※1 Report 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: FY2021 (April 2021 – March 2022)
Given the global impact of COVID-19, the seminars in this fiscal year were delivered online.
1. Seminars (open to all regulators)
| No. | Contents | Date | Location | Number of participants Report |
|---|---|---|---|---|
| 1 | Quality Control (Herbal Medicine) (PMDA-ATC Quality Control (Herbal Medicine) Webinar 2021) |
June 22-24, 2021 | Online | 31 from 13 countries/regions Report |
| 2 | Good Registration Management (GRM) (External site / 2021 APEC GRM CoE WORKSHOP) |
September 14-16, 2021 |
Online | 28 from 7 countries/regions |
| 3 | Pediatric Review*1 (PMDA-ATC & U.S. FDA Pediatric Review Webinar 2021) |
September 21-24, 2021 | Online | 32 from 11 countries/regions Report |
| 4 | Medical Devices Review*2 (PMDA-ATC Medical Devices Webinar 2021) |
November 15-17, 2021 | Online | 32 from 17 countries/regions Report |
| 5 | Good Manufacturing Practice (GMP) (PMDA-ATC GMP Inspection Webinar 2021) |
November 25-26, 2021 | Online | 29 from 19 countries/regions Report |
| 6 | Pharmaceuticals Review (PMDA-ATC Pharmaceuticals Review Webinar 2021) |
December 6-8, 2021 | Online | 34 from 12 countries/regions Report |
| 7 | Multi-Regional Clinical Trial (MRCT)*2,*3 (PMDA-ATC with National Cancer Center MRCT Webinar 2022) |
January 18-21, 2022 | Online | 39 from 13countries/regions Report |
| 8 | Pharmacovigilance*2 (PMDA-ATC Pharmacovigilance Webinar 2022) |
January 31, February 2-4, 2022 |
Online | 24 from 10 countries/regions Report |
*1 Joint Seminar with U.S.FDA, *2 APEC-LSIF-RHSC CoE Workshop, *3 Collaboration with National Cancer Center Japan
2. Other Seminars (for specific members)
| No. | Contents | Date | Location | Number of participants Report |
|---|---|---|---|---|
| 1 | Pharmaceuticals Review etc. | May, 2021 - March, 2022 | Online (for SFDA, Saudi Arabia ) |
approx 30 |
| 2 | Regenerative Medicinal Products Review | June 3, 2021 | Online (for CDSCO, India) |
39 Report |
| 3 | Medical Devices Review (Reprocessed Single-Use Medical Devices (R-SUD)) | July 16, 2021 | Online (for Thai FDA) |
8 Report |
| 4 | Good Manufacturing Practice (GMP) |
July 27, 2021 | Online (for FDA Philippines) |
51 Report |
| 5 | Medical Devices Review (PMDA-ATC/AMDC Medical Device Webinar 2021) |
August 25-26, 2021 | Online (for AMDC member states) |
100 Report |
| 6 | Medical Devices Review (Reprocessed Single-Use Medical Devices (R-SUD)) | September 1, 2021 | Online (for MDA, Malaysia) |
32 Report |
| 7 | Good Clinical Practice (GCP) |
September 8, 2021 | Online (for FDA Philippines) |
59 Report |
| 8 | Pharmacovigilance | October 4, 2021 | Online (for NPRA, Malaysia) |
41 Report |
| 9 | COVID-19 related In Vitro Diagnostics (IVDs) Review | February 8, 2022 | Online (for MDA, Malaysia) |
66 Report |
| 10 | COVID-19 related Medical Products | March 30, 2022 |
Online (for DAV, Vietnam) |
11 Report |
Completed Trainings: FY2020 (April 2020 – March 2021)
Given the global impact pf COVID-19, the seminars in this fiscal year were delivered online.
For PMDA-ATC, this is the first attempt to provide online seminars.
| No. | Contents | Date | Location | Number of participants Report |
|---|---|---|---|---|
| 1 | Medical Devices Review (PMDA-ATC Medical Device Webinar 2020 for Thai FDA) |
August 26-27, 2020 | Online (for Thai FDA) |
17 from Thailand Report |
| 2 | Quality Control (Herbal Medicine) (PMDA-ATC Quality Control (Herbal Medicine) Webinar 2020) |
September 9-11, 2020 | Online | 30 from 15 countries/regions Report |
| 3 | Pediatric Review*1 (PMDA-ATC & U.S. FDA Pediatric Review Webinar 2020) |
September 28-October 1, 2020 | Online | 27 from 11 countries/regions Report |
| 4 | Japanese Pharmacopoeia (PMDA-ATC Japanese Pharmacopoeia Webinar 2020 for Thai FDA) |
October 20, 2020 | Online (for Thai FDA) |
20 from Thailand Report |
| 5 | Pharmaceuticals Review (PMDA-ATC Pharmaceuticals Review Webinar 2020 for NPRA, Malaysia) |
November 6, 2020 | Online (for Malaysia NPRA) |
19 from Malaysia Report |
| 6 | Medical Devices Review *2 (PMDA-ATC Medical Devices Webinar 2020) |
November 16-20, 2020 | Online | 27 from 18 countries/regions Report |
| 7 | Pharmaceuticals Review (PMDA-ATC Pharmaceuticals Review Webinar 2020 for DAV, Vietnam) |
December 2, 2020 | Online (for Vietnam DAV) | 6 from Vietnam Report |
| 8 | Pharmaceuticals Review (PMDA-ATC Pharmaceuticals Review Webinar 2020) |
December 15-17, 2020 | Online | 26 from 14 countries/regions Report |
| 9 | Multi-Regional Clinical Trial (MRCT)*2,*3 (PMDA-ATC with National Cancer Center MRCT Webinar 2021) |
January 18-21, 2021 | Online | 25 from 8 countries/regions Report |
| 10 | Pharmacovigilance*2 (PMDA-ATC Pharmacovigilance Webinar 2021) |
February 1-4, 2021 | Online | 26 from 15 countries/regions Report |
| 11 | Regenerative Medicinal Products Review (PMDA-ATC Regenerative Medicinal Products Review Webinar 2021 for NPRA, Malaysia) |
March 19, 2021 | Online (for Malaysia NPRA) |
53 from Malaysia Report |
*1 Joint Seminar with U.S.FDA, *2 APEC-LSIF-RHSC CoE Workshop, *3 Collaboration with National Cancer Center Japan
Completed Trainings: FY2019 (April 2019 – March 2020)
| No. | Contents | Date | Location | Number of participants Report |
|---|---|---|---|---|
| 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 |