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- E-learning Courses : Pharmaceuticals Review
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E-learning Courses : Pharmaceuticals Review
This E-learning courses are organized for regulators only.
Registration is necessary in advance.
Total: 87 min Updated 2022.10.18
| No. | Title | Duration |
| 1 | Review Team | 2 min |
| 2 | Application Dossier | 3 min |
| 3 | Review Process of New Drugs | 11 min |
| 4 | Japanese Pharmacopoeia (JP) | 10 min |
| 5 | Review of Chemistry Manufacturing and Control (CMC) | 10 min |
| 6 | First-in-Human studies | 5 min |
| 7 | Regulations for Clinical trials | 9 min |
| 8 | Benefit/Risk balance evaluation of New Drugs | 3 min |
| 9 | Review of Generic drugs | 9 min |
| 10 | Bioequivalence Study | 10 min |
| 11 | Expedited regulatory pathways | 10 min |
| 12 | Consultation Service | 5 min |
