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