detailed-guide-regarding-eudravigilance-data-management- ... - EMA
The phrase appears to be a specific, internal file or code name associated with the European Medicines Agency (EMA) and its Good Pharmacovigilance Practices (GVP) . Specifically, this string is found in the metadata of the detailed guide regarding monitoring medical literature , which outlines the entry of relevant information into the EudraVigilance database. Purpose of the Guide
The document provides a structured workflow for processing adverse drug reaction (ADR) data: major_spz_x_dwie_belki_gwiazdka_konopie_prod_at...
: Formatting requirements for recording information in the EudraVigilance database, including author names and journal details in Vancouver style . Regulatory Context
: Clear identification of the substance or medicinal product involved. detailed-guide-regarding-eudravigilance-data-management-
This "detailed guide" is part of a broader set of that govern pharmacovigilance in the EU. It is specifically tied to Module VI , which handles the collection, management, and submission of reports for suspected adverse reactions.
: Specific details like gender or age must be present. Purpose of the Guide The document provides a
: Establishes strict rules for what qualifies as a valid ICSR.