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GCP and Guideline Updates |
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Date: 10/02/2010 |
| Type: Guideline |
| Region: Europe |
Subject: Eudralex Vol 10 - New Q&A on AE reporting
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| A new Q and A document has been added to Chapter II of Eudralex Vol 10 http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-10/guideline.pdf
This document reiterates much of the guidance in ICH E2A and the EU Directives, but also clarifies some issues such as timelines for SUSARs which are not fatal or lifethreatening to begin with but become so after reporting.
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