PHARMACO-VIGILANCE AND PHARMACOEPIDEMIOLOGY

The history of pharmacovigilance. Objectives. Definitions. Classification of adverse drug reactions. Clinical Trials: collection of safety data and establishing the adverse drug reaction profile. Causality assessment. Dictionaries and coding in pharmacovigilance. Report forms. Pharmacovigilance guidelines. The European scenario. The Italian pharmacovigilance legislation. Periodic Safety Update Report. Eudravigilance. Risk Management Plan.. An overview of vaccine safety surveillance. An overview of veterinary safety surveillance. The role of Sales Representatives. Pharmacoepidemiology (definition, objectives, models).