CMC ANALYTICAL, COMPARABILITY AND STABILITY STUDIES FOR
The course will provide attendees with a comprehensive overview of the phase-specific requirements for CMC analytical characterization, comparability, release and stability of biotechnology products. The course will offer a clear, concise, but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful design, implementation and documentation of the required CMC analytical and stability studies for biotechnology products, including emerging biosimilar products. Key deliverables from each phase of development will be illustrated. Current 'hot-button' CMC analytical and stability issues as well as strategies for preventing (or remediating) gaps will be presented. Attendees will be given a CD containing a complete set of all regulatory documents and industry white papers currently applicable to biotechnology product analytical CMC requirements that covers the entire product development lifecycle. Why you should attend; - Create compliant stability protocols - Ensure EU and FDA regulatory compliance - Identify specifications for release On October - October at 9:00 am - 5:00 pm. Artist / Speaker: Dr Nadine Ritter. Prices: Book before the 10th September: £% VAT = £, Book after the 10th September: £% VAT = £.