Master in Regulation and Evaluation of Medicines and Health Products




Learning outcomes

To develop general konwledge in the following topics : benefit-risk assessment methodology and medines making decision process by stakeholders and Medicines Autority Agency.To understand the basic principles of quality management systems and its use in pharmacovigilance. Risk management plans and risk minimisation programes. Risk management in clinical practice. Risk communication. Pharmacovigilance system in Europe and Portugal.


Clinical pharmacological and genetics issues underlying medicines safety
Clinical trials and epidemiologic studies methodologies and evaluation
Scientific evidence limitations in the risk-benefit medicines assessment
Risk management plans and its minimisation measures
Benefit-risk assessment methods in daily practice
Methods for Drug Safety Intensive Monitoring
Safety signal generation
National and european regulations and guidelines concerning pharmacovigilance.
Causality assessement
Risk communication, its tools and its place linked to the use of medicines.