CMC Management in Regulatory Affairs - Online-Training: Quality data for marketing authorisation in Europe
- 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
This online-training will provide you with practical information on CMC requirements for marketing authorisation in the ICH region. Our experts will pass on their indepth knowledge of challenges with essential quality data, CMC writing and global lifecycle management.
Termin
| Datum: | 26.10.2021 |
| Ort: | Online - Online |
| Preis: | 1.790,00 EUR zzgl. MwSt. |
Zielgruppe
This seminar will particularly benefit CMC managers, regulatory affairs managers and quality assurance specialists dealing with
the
- compilation and the maintenance of CTD Module 3 and/or the
- classification of quality-related changes.
Kontaktinformationen
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