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European Regulatory Affairs

  January 24, 2007  
Drug Information Association, Renaissance Penta Vienna Hotel, Ungargasse 60, Vienna, Austria
Jun 4 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.

The workshop will provide strategic advice on how to file applications for the marketing authorizations in the European Union for staff involved in International Regulatory Affairs.

Key Topics
•European Union
•Centralized 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.

Organized by: Drug Information Association
Invited Speakers: Brenton E. James
Consultant in Strategic Regulatory Affairs in the European Union, Ascot, UK.
Deadline for Abstracts: -
Registration: http://www.diahome.org/product/12638/07519.pdf
E-mail: dia@diahome.org
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