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Consulting in „Expedited Reporting“ of serious adverse reactions, SAR (15 days or 7 days reports), especially in „not labelled“ reactions – SUSAR – to be reported to authorities and Ethics Committees according to the European Directive 20/2001/EC, FDA and/or local laws, respectively Electronic Reporting Systems: central reporting of SUSAR to the EMEA; support and consulting in the development / selection / validation of systems

Arzneimittelinstitut

Dr. Peter M. Kaiser

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+ 49 5151 925633

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Niederdorf 3
31789 Hameln

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info@auditpmk.de

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