This E-learning courses are organized for regulators only.
Registration is necessary in advance.
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 |