MANAGEMENT OF ADVERSE EVENTS
Safety.DB (Safety Database Network Management System) is the service available to pharmaceutical companies for complying with the implementation of
pharmacovigilance.
The system was developed in a way to be compliant with the regulations and the standards of EUDRA VIGILANCE
(ICH - Format E2BM) and is arranged for the functions of
"Electronic Submission" of the events to the EUDRA DB database.
Safety.DB was also created as an instrument of support for the post-marketing phase in connection with the most recent
European directives on the prompt exchange of information on pharmaceuticals.
The development of the application was brought about by the experience acquired by GM in the realization of
CTDMS
system for integrated management of clinical and epidemiologic research activities.
The Safety.DB system can be acquired completely independent from the CTDMS
system or as an integrated application module within this system.
Safety.DB is a web based application for the management of the entire cycle of
pharmacovigilance.
The web architecture makes it available at any location equipped with an Internet connection
so that the users can work from any workstation independent from their geographic location.
The modular structure, moreover, allows for an easy adjustment to future regulatory standards and consequential administrative requirements.
The structure of the documents generated complies with the ICHICSR
DTD 2.1 specifications and to the general rules defined by
EMEA.
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