Abstract Information Technology (IT) and specialized systems could have a prominent role
towards the support of drug safety processes, both in the clinical context but also beyond …

Abstract Background Adverse drug reactions (ADRs) are regarded as a major cause of
death and a major contributor to public health costs. For the active surveillance of drug …

Abstract Information Technology (IT) could have a prominent role towards the “Active
Pharmacovigilance”(AP) paradigm by facilitating the analysis of potential Adverse Drug …

Abstract Objective Supplementing the Spontaneous Reporting System (SRS) with Electronic
Health Record (EHR) data for adverse drug reaction detection could augment sample size …

As new data sources have emerged, the data space which Pharmacovigilance (PV)
processes can use has significantly expanded. However, still, the currently available tools …

Pharmacovigilance (PV) encompasses all data gathering and processing activities related to
the detection, assessment, understanding, and prevention of adverse effects throughout the …

Pharmacovigilance is the science and activities relating to the detection, assessment,
understanding, and prevention of adverse effects from medicines or vaccines …

With widespread adoption of electronic health records (EHRs), Real World Data and Real
World Evidence (RWE) have been increasingly used by FDA for evaluating drug safety and …

Objective: Driven by the need of pharmacovigilance centres and companies to routinely
collect and review all available data about adverse drug reactions (ADRs) and adverse …

Purpose Pharmacovigilance methods have advanced greatly during the last decades,
making post‐market drug assessment an essential drug evaluation component. These …