Get your know-how on creating and maintaining quality data for biotech products in our online training. Including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2).
The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place and qualify now! All three course days can be booked individually (single day = 1.290€ plus VAT) - for booking, please contact us!
Non-clinical/clinical content in the dossier: Are you a beginner in the field and would like to feel confident working competently on modules 2, 4 and 5 in the future? Are you already an experienced specialist and would like to refresh, professionalise or "structure" your knowledge? Then you've come to the right place!
CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals and biologic).
