The EudraVigilance Expert Working Group (EV-EWG) has coordinated
the development of an Important Medical Event Terms (IME) list. This IME list
aims to facilitate the classification of suspected adverse reactions
as well as aggregated data analysis and case assessment in the frame of the
day-to-day pharmacovigilance activities of stakeholders in the European Union.
Important Medical Events, known clinically serious events which may not fall into the seriousness categories of hospitalization/prolongation of hospitalization, congenital anomalies, death, etc. Only, they are clinically significant. Noted; All grade IV/V of laboratory abnormalities are highly required and recommended to be considered as an SAE regardless of their outcome.
About 20% of truly serious events are deemed as non- serious AEs. Thus, the reporter and individual case reviewing parties at the manufacturing authorization holders (MAHs) are inaccurately reporting and miss out on safety signals. Be accurate, be clinically precise, be compliant.
You are not compliant and consistent. Be both.
This Global Allied Pharmaceuticals License Agreement (the "Agreement") applies to each Global Allied Pharmaceuticals Software Product that You acquire, whether it is preinstalled on or included with a GAP hardware product, acquired separately, or downloaded by you from a GAP Web site or a third-party Web site approved by GAP. It also applies to any updates or patches to these Software Products.
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