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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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European Regulatory Affairs | |
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December 24, 2007 |
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Drug Information Association, Radisson SAS, Amsterdam, Netherlands
Feb 21 2008
This 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. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development. KEY TOPICS•European Union•Centralized Procedures•Decentralized 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.
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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. JamesConsultant 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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http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=15283&eventType=Training%20Course
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E-mail:
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diaeurope@diaeurope.org
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