LFU:online

Stundents learn the general requirements, regulation and process of marketing authorization, including scientific advice. 

They gain an understanding of the regulatory procedures necessary to get a marketing authorisation, aspects of compiling a Marketing Authorisation Application (MAA) in different procedures,  legislation and procedural steps, principles of the Centralised Procedure (CP), the Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP), necessary activities in the post-marketing phase

• The Pharmaceutical Law in the EU
• The lifecycle of a medicinal product, from development, to MA, market access to post-marketing surveillance
• Scientific advice
• Marketing Authorisation Procedures
• National procedure
• Mutual Recognition/Decentralised Procedure
• Centralised Procedure
• Format of a registration dossier - Common Technical Document (CTD)
• Specific types of applications
• Determination of post-marketing surveillance, Risk Management Plans (RMPs)

Lecture with interactive elements involving student participation, audience response systems, online handouts

written exam

Modules 1 and 2