En bref :
The course will give an overview of the European regulatory system for human medicines, 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 various procedures, the clock-stops, the compiling of questions etc.
An introduction to pharmacovigilance, variations and renewals will be given in the context of the lifecycle.
The course will cover the current registration systems available for approval of human 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
Booking: http://atnd.it/39707-1
Prices:
Member Charitable Nonprofit/Academia/Government: EUR 725
Member Standard: EUR 1450
Charitable Nonprofit/Academia/Government: EUR 880
Standard: EUR 1605
Speakers: Birka Lehmann, Katarina Jelic Maiboe
Venue details: Mercure Paris La Défense Grande Arche, 17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot, Nanterre/Paris, 92000, France
