Drug Information Association, DIA, 800 Enterprise Rd., Suite 200, Horsham, PA, USA
May 19 2008
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 was effective November 2005, and how it changed access to centralized procedure and altered regulatory data protection. COURSE HIGHLIGHTS·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.
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