Drug Information Association, Renaissance Paris Hotel La Defense, 60, Jardin de Valmy, Boulevard Cirqulire Sortie 7, Paris la Defence Cedex, France
Nov 26 2007
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. Detailed review will be offered on the changed Centralized and Mutual Recognition Procedures and New Decentralized Procedure with discussion of practical examples of product types suitable for each procedure. Key Topics
•European Union
•Centralized Procedures
•De Centralized 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.
|
|