Handling collection and reporting of AEs

The most common method for obtaining information on adverse events (AEs) for subsequent reporting to regulatory authorities is spontaneous report by a patient (par. 3 of Article 64 of the Federal Law #61 dated April 12, 2010).

Collection of spontaneous reports run by Roszdravnadzor is an essential part of PhV system in the Russian Federation.

Each MA holder has to comply with regulatory requirements for GPP with respect to collection and reporting of AEs, as well as appropriate maintenance of AE databases.

The paper-based media and the existing Microsoft Office programs are not designed for most part for handling the large amounts of PhV data.

The introduction of automated software allows optimizing and effectively managing the PhV process  at appropriate level.