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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



JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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Copyright (C) Pharmaceuticals and Medical Devices Agency, All Rights Reserved.

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E-learning Courses : Pharmaceuticals Review
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