Course - Montrouge, France
This is the must-attend training course for anyone needing to learn the essentials of European Regulatory Affairs – it has been extended to two days to include more topics, and it is kept up to date in minute detail by the experienced faculty.
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 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 curernt 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.
- Directive 2001/83/EC the Community Code on the Mutual Recognition Procedures.
- Decentralised procedure and referrals.
- Organization: Propel Bikes Limited
Wed, Nov 04, 2015 - Thu, Nov 05, 2015
Mercure Paris Porte D'Orleans
13 rue François Ory, Montrouge, France
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