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- Seminar Schedule
- FY2022 (April 2022-March 2023)
Here begins the text.
FY2022 (April 2022 – March 2023)
Given the global impact of COVID-19, the seminars in this fiscal year were delivered online or hybrid.
- 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) | 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 | 26 from 17 countries/regions Report |
| 6 | Medical Devices Review (PMDA-ATC Medical Devices Webinar 2022) |
November 28-30, 2022 | Online | 21 from 13 countries/regions Report |
| 7 | Pharmaceuticals Review (PMDA-ATC Pharmaceuticals Review Webinar 2022) |
December 6-8, 2022 | Online | 35 from 16 countries/regions Report |
| 8 | Multi-Regional Clinical Trial (MRCT)*2,*3 (PMDA-ATC with National Cancer Center MRCT Webinar 2023) |
January 16-19, 2023 | Online | 27 from 13 countries/regions Report |
| 9 | Pharmacovigilance*2 (PMDA-ATC Pharmacovigilance Webinar 2023) |
February 6-9, 2023 |
Online | 31 from 16 countries/regions Report |
*1 Joint Seminar with U.S.FDA, *2 APEC-LSIF-RHSC CoE Workshop, *3 Collaboration with National Cancer Center Japan
- Other Seminars (for specific members)
| No. | Contents | Date | Location | Number of participants Report※1 |
|---|---|---|---|---|
| 1 | Risk Management Plan(RMP) (and symposium) |
May 24-25, 2022 | Online (for ASEAN PPWG members) |
28 from 10 countries/regions Report |
| 2 | Good Registration Management (GRM) | June 22, 2022 | Online (for CDSCO, India) |
40 Report |
| 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 | Petaling Jaya (Malaysia), Sapporo Hybrid (for NPRA Malaysia) |
2 Report |
| 5 | First in Human | Sep 26-30, 2022 | Tokyo (for NPRA Malaysia) |
2 Report |
| 6 | COVID-19 Vaccine Review | October 24,2022 | Jakarta(Indonesia) 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 Report |
| 8 | PV (Pharmacovigilance) | November 21, 2022 | Online (for FDA Philippines) |
52 Report |
| 9 | GCP inspection in MRCT | December 6, 2022 | Online (for FDA Philippines) |
32 Report |
| 10 | Good Clinical Practice (GCP) (and symposium) |
February 22, 2023 | Bangkok, Thailand (for Thai FDA) |
32 Report |
| 11 | CMC Review | March 9,2023 | Online (for Indonesian FDA) | 122 Report |
*1 JICA : Japan International Cooperation Agency