- Statistical aspects in the validation of bioanalytical methods - Quality requirements for biologics in clinical studies: Clinical trials vs. marketing authorization - New clinical trial designs - Vendor oversight in a functional outsourcing concept...
- Concept: Five weekly live webcasts à 2 hours with longtime experienced speakers - Topics covered: Non-clinical aspects, principles and challenges during drug development, regulatory requirements, CQA and analytical tools, formulation - Your benefit...
CTD: Modul 2.3 & 3: - Datendarstellung im Modul 3 - Essentials des Quality Overall Summary - Fehler & Mängel Dossier & Variation: - Überführung der Daten ins eCTD - Variations & das Qualitätsdossier - Neue Trends im Rahmen von ICH Q11/Q12 und GMP ASM...