CMC Management in Regulatory Affairs - Quality data for marketing authorisation in Europe
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar and get qualified.
- Regulatory requirements in the EU and the ICH region
- Essential quality data for marketing authorisation
- CMC documentation:
Module 3, ASMF, CEP and Quality Overall Summary
- Management of post-approval changes
- Classification of quality related variations
| Veranstaltungs-Code | FB24-278405-61077509 |
Bildungsziel der Schulung:
This training will provide you with practical information on CMC requirements for marketing authorisation in the ICH region.
Our experts will pass on their in-depth knowledge of challenges with essential quality data, CMC writing and global lifecycle management.
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The content focus is on small molecules, biologics will be addressed during another event, see seminar recommendation.
Veranstaltungsort:
Online-Webinar
weitere Orte/Termine
Kursart:
Online-Webinar
Kostenlos Info anfordern
