Biopharmaceuticals - Development, manufacturing and analytics of monoclonal antibodies and other proteins - Webinar von FORUM Institut für Management GmbH

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 --- Biopharmaceutical analytics on 26 June 2024: - Method validation - Stability testing - SpecificationsThe 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 (a single day of your choice = 1.190€ plus VAT) - for booking, please contact us!

After Day 1, you will be familiar with the specialties of galenic development process technologies and you will know what to look out for in process changes and comparability studies.- After day 2, you will be aware of critical quality parameters of biologics and biosimilars and know the challenges of the non-clinical program.- After day 3, you will have gained expertise in method validation, stability testing and specification writing.- Following Day 3, you will receive the access data for the optional online test for learning success control by e-mail.

This course is aimed at specialists and managers in the pharmaceutical industry who are involved in the development, production and analysis of biotechnological drugs.- The focus on all three days will be on familiarising you with the regulatory framework with reference to guidelines. - In particular, employees in the departments of research & development, regulatory affairs, manufacturing, analytics, quality assurance and quality control will benefit from attending.