EU Directive 2001 Preloader

EU Directive 2001 - PowerPoint PPT Presentation


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Objectives of Directive. Reduce delays by simplifying and harmonising procedures Establish legal basis for implementation of GCPEstablish legal basis for application of GMP to investigational products Establish legal basis for implementation of Adverse Reactions (EU-wide pharmacovigilance)Establish Community database, trials content, initiation, terminationReinforce the ethical principles of the Declaration of Helsinki on research on human subjects.

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