Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance".
Pharmacovigilance (PV) is the science relating to the detection, assessment, understanding and prevention of the adverse effects of medicines. Systems must be in place to enable the identification, recording, reporting and analysis of safety information so that any safety signals that arise during a trial are quickly identified and acted upon.
For Clinical Trials of Investigational Medicinal Products (CTIMPs), the sponsor’s responsibilities for PV are defined in Part 5 of the Medicines for Human Use (Clinical Trials) Regulations SI 2004 1031.