3rd semester

Learning objectives

Pharmacovigilance contains the activities related to the study of the adverse effects of drugs in the context of the Hippocratic philosophy of patient benefit and no harm. Students in this course familiarize themselves with the activities related to the detection, evaluation and avoidance of the negative consequences of the use of drugs under the light of Public Health. They are informed about the regulatory framework for the operation of the EOF and about practices for raising awareness and informing health professionals about the safe use of medicines.

Course content

Evidence for detecting, evaluating, understanding and preventing adverse drug reactions and other problems related to the use of drugs. Drug safety controls on the market, patients' rights. Pharmacovigilance systems, summary regulatory framework for the operation of national and European drug organizations, information networks of health professionals, drug marketing authorization systems, yellow card, use and exploitation of data for the protection of public health.