No. | Contents | Date | Location | Number of participants Report |
---|---|---|---|---|
1 | Pediatric Review (Note 1) (PMDA-ATC & U.S. FDA Pediatric Review Seminar 2023) |
July 10 to 13, 2023 |
Tokyo(PMDA) | 25 from 8 countries/regions Report |
2 | Quality Control (Herbal Medicine) (PMDA-ATC Quality Control (Herbal Medicine) Seminar 2023) |
August 22 to 24, 2023 |
Toyama prefecture | 13 from 8 countries/regions Report |
3 | Good Registration Management (GRM)(External site / 2023 APEC GRM CoE WORKSHOP) | September 6 to 8, 2023 |
Taipei, Chinese Taipei | |
4 | Pharmaceuticals Review (PMDA-ATC Pharmaceuticals Review Webinar 2023) |
September 26 to 28, 2023 |
Online | 29 from 13 countries/regions Report |
5 | Medical Devices Review (Note 2) (APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2023) |
November 14 to 16, 2023 |
Online | |
6 | Medical Devices Review (PMDA-ATC Medical Devices Seminar 2023) |
December 5 to 7, 2023 |
Tokyo (PMDA) | |
7 | Multi-Regional Clinical Trial (MRCT) (Note 2), (Note 3) (PMDA-ATC with National Cancer Center MRCT Seminar 2024) |
January 23 to 26, 2024 |
Tokyo (PMDA) | |
8 | Good Manufacturing Practice (GMP)(PMDA-ATC GMP inspection Webinar 2024) | February 6 to 7, 2024 |
Online | |
9 | Pharmacovigilance (Note 2) (PMDA-ATC Pharmacovigilance Webinar 2024) |
February 26 to 29, 2024 |
Online |
(Note 1) Joint Seminar with U.S.FDA, (Note 2) APEC RHSC CoE Workshop, (Note 3) Collaboration with National Cancer Center Japan
Please refer to the Frequently Asked Questions (FAQ).
No. | Contents | Date | Location | Number of participants Report |
---|---|---|---|---|
1 | Pharmaceutical Review | April 20, 2023 |
Tokyo (PMDA) (for DAV Vietnam) |
7 Report |
2 | Risk Management Plan (RMP) | May 25 to 26, 2023 |
Jakarta, Indonesia (for ASEAN PPWG members) |
39 from 10 countries/regions |
3 | Good Manufacturing Practice (GMP) | May 29, 2023 |
New Delhi, India (for CDSCO, India) |
80 Report |
4 | Regenerative Medicinal Products Review | June 28, 2023 | Online (for CDSCO, India) |
30 Report |
5 | Pharmaceuticals Review | July 20 to 21 and 24 to 26, 2023 |
Tokyo (PMDA) and Toyama Prefecture (for JICA (Note 1) trainees) |
6 from 6 countries/regions Report |
6 | First in Human studies of Regenerative Medical Products | July 26, 2023 | Online (for NPRA, Malaysia) |
23 Report |
7 | Medical Devices Review (PMDA-ATC/AMDC Medical Devices Webinar 2023) |
December 4, 2023 | Online (for AMDC member states) |
(Note 1) JICA : Japan International Cooperation Agency
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