Training Course in Pharmacovigilance and Risk Assessment
General Objectives of the CoursePharmacovigilance is a scientific area focused on the identification, validation, quantification, evaluation and minimization of adverse effects of medicines and health products, oriented to promote safety of drugs and evaluation of the benefit-risk. These objectives require constant adaptation of the Pharmacovigilance Centres to the new characteristics of the pharmaceutical market, in particular to regulatory affairs. European legislation .has grow exponentially during the last years which requires updated formation of professionals.
Licentiates in Pharmacy. Masters in Pharmaceutical Sciences
Candidates should check the admission requirements available on this site, in addition to the information provided here.
Mode of StudyFace-to-face
Teaching / Evaluation language(s)Portuguese
Examination Regulations, Assessment and GradingFinal classification is awarded through a final exam quoted between 0 and 20.
Learning Objectives and Intended Skillsa)Pharmacovigilance and benefit-risk assessement through the life of the drug product; most relevant models in epidemiologic investigation. Safety after MA (marketing authorization);
b)Adverse effects: clinical and epidemiological issues. Pharmacovigilance system in Portugal; regulatory evolution; detection, notification and evaluation of adverse effects;
c)Risk assessement. European risk plans.
Francisco Jorge Batel Marques
Qualification Requirements and RegulationsNot applicable
Non Degree Course
Qualification Awarded: Diploma/Certificate
Duration: 30 HORAS
ECTS Credits: 3.0