This is a 3-day stand-alone short course. It consists in a series of learning events, namely lectures, seminars, presentations, discussion panels and case studies. Pre-course distance-learning activities will also be available for the interested participants.
On successful completion of this Module the student should be able to: Explain the role of Pharmacovigilance in monitoring of drugs in non-clinical & clinical research and in the marketplace. Appraise common nomenclature associated with pharmacovigilance (including AE & ADR, Listedness, Expectedness, etc). Demonstrate the sources of safety data: methods for collection, analysis, interpretation and reporting drug safety data, including electronic safety data reporting. Evaluate the assessment of causality. Analyse the application of signal generation and handling of drug safety data in pre-marketing (clinical trial) and post-marketing (pharmacovigilance) contexts, including automated methods. Explain the principles of pharmacoepidemiology and examine the different types of pharmacoepidemiological studies used in evaluating drug safety including the choice of the most appropriate study design. Describe pharmacovigilance aspects of medicines regulation throughout the life-cycle of a medicine. Critically appraise the principles of risk-benefit analysis and management using qualitative and quantitative approaches. Evaluate the background and purposes of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Describe the role of the EU Qualified Person in PharmacoVigilance (QPPV). Describe major routes for reporting and communication of pharmacovigilance data. Evaluate the aetiology, mechanisms and pathology of major classes of adverse drug reactions and interactions.