Essensials of European Regulatory Affairs

Gain an overview of the European Network, Marketing Authorisation for Medicinal products in the EU and Lifecycle Management.

23-24 Jun 2014 at NH Musica, Amsterdam, Netherlands

Pharmaceuticals/Drug Discovery

Essensials of European Regulatory Affairs 23-24 Jun 2014 NH Musica, Amsterdam, Netherlands
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Gain an overview of the European Network, Marketing Authorisation for Medicinal products in the EU and Lifecycle Management.

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

Price: Member Industry: €1,420.00, Non-member Industry: €1,550.00, Member Academia/Charitable/Government/Non-profit (Full-time): €710.00, Non-member Academia/Charitable/Government/Non-profit (Full-time): €840.00

When
From: June 23, 2014 08:00
To: June 24, 2014 16:30
Where

NH Musica, 221 Van Leijenberghlaan, 1082 GG, Amsterdam, Netherlands

Category

Pharmaceuticals/Drug Discovery

Contact email
talana.bertschi@diaeurope.org

Contact phone
+41 61 225 5151

External link

Submitted by:

evvnt Platform

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