Medication Safety and Risk Management

Curso de Formação

Ano Letivo 2024/2025

This course will address one of the most important areas in the development and use of medicines ? Risk Management and Medicine Safety ? of which the best-known facet is Pharmacovigilance. Whether in the clinical trial phases or after market introduction, the objective of this course is a global introduction to the topic and the subsequent integration of knowledge in the main dimensions of risk management and drug safety. The course will present the following contents: introduction to pharmacovigilance; the National Pharmacovigilance System (SNF); the European and Global Pharmacovigilance System; regulatory aspects; spontaneous reporting of adverse drug reactions; assessment of drug safety; pharmacovigilance research methodologies and databases; periodic safety reports; risk management plans and measures; and artificial intelligence and machine learning in pharmacovigilance: potential and challenges. Safety in the use of medication, its promotion and risk management should be transversal objectives throughout the student's learning and performance, which can be enhanced by the correct understanding of the remaining contents, all of which are interspersed in monitoring the use of medicines. medicines by the population, whether at the level of health services or the community level. The dissemination and awareness of pharmacovigilance and the SNF is also one of the goals of this training. The course results from the collaboration between the University of Évora and INFARMED, I.P.