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) | 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 Repor |