Key Roles and Stakeholders in Medicines Risk Communication: Duties and Challenges Methods in Clinical Research, Pharmacoepidemiology and in the Assessment of the Efficacy of Medicines Pharmacovigilance Regulations Pharmacovigilance Regulatory Processes Principles of Identifying and Recognizing Adverse Events and Safety Signals Principles of Pharmacoeconomics and Valuation of Health States Principles of Pharmacovigilance Substantiation and Quantification of Risks The Public Health Impact of Adverse Drug Reactions Critical Appraisal of Clinical Trials: Evidence-Based Medicine and its Uncertainties Drug Utilisation Studies: Introduction and Quantitative Methods Drug Utilisation Studies: Qualitative Methods