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Essentials of European Regulatory Affairs

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The course will give an overview of the European regulatory system, including the legislative processes and European Networks, the different routes for obtaining a licence for the European market, the centralised, the decentralised and the mutual recognition procedures, and the national procedures. In addition the specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products will be discussed. This will cover the different steps and timelines in the different procedures, the clock-stops, the compiling of questions etc.  

An introduction regarding the lifecycle will be given by information in respect to pharmacovigilance, variations and renewals.

The course will cover the actual registration systems available for approval of medicinal products:

  • Regulation EC726/2004 on the centralised procedure, including specific marketing authorisations and the European Medicines Agency
  • Directive 2001/83/EC ‘the Community Code’ on the Mutual Recognition Procedures
  • Decentralised procedure and referrals
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