Pharmacovigilance

World Health Organization (WHO) defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. It aims to promote the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and public

Adverse Drug Reaction, as per WHO 1972 is defined as a response to a drug which is noxious and unintended and which occurs at doses normally used in human for the prophylaxis, diagnosis or therapy of disease or for the modifications of physiological function

Adverse Events, is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.