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Pharmacovigilance is defined by the World Health Organization (WHO) as "the science and practises relating to the detection, evaluation, understanding, and prevention of adverse drug reactions and other medicine-related problems." Pharmacovigilance's definition and scope have developed as a result of a systems approach. As a result, pharmacovigilance is a delicate field. It involves keeping an eye on the safety of drugs and taking steps to limit risk while maximising benefit. The management of pharmacovigilance data is not only inefficient, but it is also ineffective. As a result, establishing a comprehensive pharmacovigilance data management system that conforms with severe regulatory criteria, worldwide pharmaceutical conventions, and ultimately protects the pharmacovigilance end users, the patients, is critical. Implementation of business management software would be an ideal approach for improved data management, process harmonisation, data security, and time savings due to excessive manual labour dependency. In pharmacovigilance, case processing is a fundamental activity. It provides data for the analysis of adverse effects that allows to detect new safety concerns and to periodically assess the benefit to risk ratio associated with the use of a pharmaceutical product. The precision and quality of safety data processing, also from the medical point of view, is crucial for ensuring correct analysis and undertaking corrective actions in timely manner, which in turn helps to safeguard the health of the patients and allows safe use of the drug. Consequently, every company that markets even a handful of products across many countries, gathers thousands of reports per year. The only way to manage this data load is using latest software and automation

KEYWORDS:- ICSR, causality assessment, benefit-risk profile, safety database, automating case processing