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Drug Information Association, Hilton San Diego/Del Mar, Del Mar, CA, USA
Jan 28 2008
This course is designed to present a comprehensive overview of theEvolution 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. KEY TOPICSCentralized, 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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Organized by:
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Drug Information Association |
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Invited Speakers:
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Brenton E. James, Consultant in Strategic Regulatory Affairs in the European Union,Ascot, UK.
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Deadline for Abstracts:
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-
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Registration:
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on our website.
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E-mail:
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dia@diahome.org
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