: Instructions for performing "duplicate checks" to avoid redundant entries when the same case appears in multiple databases or journals.
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
: Formatting requirements for recording information in the EudraVigilance database, including author names and journal details in Vancouver style . Regulatory Context major_spz_x_dwie_belki_gwiazdka_konopie_prod_at...
: Confirmation that a primary source (e.g., doctor, patient) exists.
detailed-guide-regarding-eudravigilance-data-management- ... - EMA : Instructions for performing "duplicate checks" to avoid
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.
The document provides a structured workflow for processing adverse drug reaction (ADR) data: Purpose of the Guide : Formatting requirements for
: Guidance on how the EMA monitors literature for certain active substances, reducing the duplicative workload for MAHs.