European Regulatory Procedures – Comprehensive Overview of EMA and National Requirements

Berlin, Germany (February, 20 - 21, 2017)

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.

The course will also outline how variations to the marketing authorisation, as well as authorisation of specific groups of products such as orphan, paediatric, advanced therapy and herbal medicinal products are handled in the EU. The transparency of EU regulatory decision making will be demonstrated via review and navigation of EU regulatory websites. The impact of key emerging trends already affecting or likely to impact on European pharmaceutical registrations in the future will be discussed.

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