Abstract

This course will give participants the necessary overview of the application procedures and regulatory filing pathways used within Europe to grant marketing authorisations for medicinal products, and of the agencies and institutions that control the regulatory process. Special focus will be given to the European Medicines Agency (EMA) and the Centralised Procedure (CP), with the role of the national health authorities and other EU bodies in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) explained also. Factors affecting the choice of procedure will be discussed, as well as best practice in the management of the procedures. A workshop session will engage participants in a case study evaluating the options for submission of a marketing authorization application.