LFU:online

·         General requirements, regulation and process of marketing authorization, including scientific advice

·         Gain an understanding of the regulatory procedures necessary to get a marketing authorisation

·         Learn about aspects of compiling a Marketing Authorisation Application (MAA) in different procedures

·         Learn about legislation and procedural steps

·         Understand the principles of the Centralised Procedure (CP), the Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP),

·         Learn about 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

o    National procedure

o    Mutual Recognition/Decentralised Procedure

o    Centralised Procedure

·         Format of a registration dossier - Common Technical Document (CTD)

·         Specific types of applications

·         Determination of post-marketing surveillance, Risk Management Plans (RMPs)

Vorlesung (Computer-unterstützte visualisierte Präsentation, online Handouts)

schriftlich

Modules 1 and 2