European Regulatory Affairs

Venue: Hilton San Diego/Del Mar

Location: Del Mar, California, United States

Event Date/Time: Oct 29, 2007
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This course is designed to present a comprehensive overview of the
Evolution of the registration systems available for approval of products in the European Union (EU) since 1995. It reviews Centralized, Mutual Recognition, and national registration procedures in detail, and includes practical examples of product types particularly suited to each procedure. There will also be a discussion on the new medicines legislation, which is effective November 2005, and how it changes access to centralized procedure and alters regulatory data protection.

Centralized, Mutual Recognition, and National Registration Procedures in the EU
Official Regulatory Policies and Other Issues Pertinent to Successful EU Regulatory Strategy
EU Regulatory Strategy Pertinent to Commercial, Business, and Licensing Arrangements
Trademarks and Patents
Medical Devices
Clinical Trial Directive
Legal Status and Switching.