- 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...
Development & manufacturing on 24 June 2024: - Manufacturing process - Formulation - Process changes --- Regulatotory requirements on 25 June 2024: - IMPD quality part - Non clinical aspects - Regulatory update: Biologics und biosimilars --- Biopharm...