EN ISO 27953-2:2011 PDF
Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011)
Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 588
- Дата публикации:
- 1 декабря 2011 г.
- Издание:
- CEN EN 27953 edition 1 version 1
- ICS:
- 35.240.80
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.
Abstract
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