What is pharmacovigilance?
Pharmacovigilance is the science and activities concerned with detecting, analyzing and evaluating side effects of drugs and problems related to their use with the aim of reducing or preventing their occurrence (WHO 2002)
What is a side event?
An adverse event is any undesirable medical event in a patient or volunteer in a clinical study that is not necessarily caused by treatment.
What is the side effect of the drug?
It is the patient’s unintended, unwanted or undesirable response to a drug, including abnormal laboratory results that occur when the patient takes approved doses of the drug.