The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005.
The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail.
The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in International Regulatory Affairs.

- European Union
- Centralised Procedures
- Decentralised Procedure
- Mutual Recognition Procedure
- National Procedure
- Key issues to consider for business opportunities
- Regulatory strategy
- Legal status of products and switching from Rx to OTC
- Medical Devices Legislation
- Clinical Trial Directive.