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Homepage>CSN Standards>98 Health Informatics>9810 The main conceptual structure of a common class of terminological systems - Reports on patient>CSN EN ISO 27953-2 - Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR
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CSN EN ISO 27953-2 - Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR

CSN EN ISO 27953-2

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR

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English Hardcopy
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457.78 USD
Category:981030
Released:2011
Number of Standard:CSN EN ISO 27953-2
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EN ISO 27953-2


EN ISO 27953-2 Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR - ISO 27593-2:2011 seeks to create a standardized framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination.

Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.
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