What Students Need To Know About History of Pharamcovigilance

Pharmacovigilance (PV) is defined by the European Commission (EU) as the “Process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines”. Pharmacovigilance activities contribute to the protection and promotion of public health through preventing harm caused by medicines as well as by enabling the safe and effective use of medicines. In Europe, pharmacovigilance activities are performed by regulators and pharmaceutical companies, including risk management planning, collecting and managing suspected adverse reaction (ADR) reports, signal detection and management, and post-authorisations studies that enable the generation of new information about marketed medicines. The international PV systems aim to monitor the risk/benefit ratio of drugs as well as improve patients’ safety and their quality of life. PV activities include: collecting and managing data on the safety of medicines, looking at individual case reports to detect new “signals”,