European Regulatory Affairs

Venue: Radisson Blu Alcron Hotel

Location: Prague, Czech Republic

Event Date/Time: Jun 03, 2010 End Date/Time: May 04, 2010
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This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory
affairs, clinical research, project management and other disciplines involved in the development of medicinal products.
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.

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