LFU:online

Understand drug bio-equivalence and data protection

·         Generics …. including bioequivalence

·         Biosimilar Framework in EU and on global level – concept and guidelines

·         Development and marketing authorisation of biosimilars

·         Reimbursement of biosimilars

·         Legal aspects

•    What is a biosimilar – how did it all start / first biosimilar products in EU
•    Development approach of biosimilar vs biologic
•    Biosimilarity assessment / comparability to reference product at all development stages, variability of biologics
•    Increasing importance of biosimilars

Lehrveranstaltung mit immanentem Prüfungscharakter bestehend aus regelmäßiger Überprüfungen, Mitarbeit und Portfolio der Übungsaufgaben

Modules 1 and 2