Objectives : To understand how to evaluate the effects of medicines and therapeutic interventions both during drug development and clinical use To know the main methodological and ethical characteristics and limitations of randomized clinical trials To understand the differences between efficacy and effectiveness To know the basic concepts and classification of the pharmacoepidemiological studies designed to evaluate therapeutic interventions To identify information gaps in selected therapeutic areas (e.g. cardiovascular, psychiatry, diabetes care) Topics covered: Patients, medicines and prescribing in society. Life cycle of medicines. The knowledge-building process of the effects and adverse effects of medicines during their development and clinical use. Overview of studies to detect and to evaluate the risk associated with therapeutic interventions. Scope, uses and limitations. The need to monitor the medicines prescribing process. Introduction to the study of the use of medicines in clinical practice.