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The EU Clinical Trials Directive has provided Europe with its most comprehensive revision of clinical trial process. At the heart of this revision was expedited (including electronic) and annual safety reporting. Furthermore, post-marketing surveillance in the new 27 Member State Europe has never been more detailed. Electronic safety reporting, new pharmacovigilance inspections, the role of the Qualified Person for pharmacovigilance, licensing agreements and safety data exchange, and the revised Volume IXa are all new challenges that face multi-national companies. This course provides pharmacovigilance personnel with the tools to remain compliant, and the knowledge of what needs to be reported when and to whom.

The EU Clinical Trials Directive has provided Europe with its most comprehensive revision of clinical trial process. At the heart of this revision was expedited (including electronic) and annual safety reporting. Furthermore, post-marketing surveillance in the new 27 Member State Europe has never been more detailed. Electronic safety reporting, new pharmacovigilance inspections, the role of the...

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