Training Course in Pharmacovigilance and Risk Assessment

General Objectives of the Course

Pharmacovigilance 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.

Admission Requirements

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 Study

Face-to-face

Teaching / Evaluation language(s)

Portuguese

Examination Regulations, Assessment and Grading

Final classification is awarded through a final exam quoted between 0 and 20.

Learning Objectives and Intended Skills

a)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.

Course Coordinator(s)

Francisco Jorge Batel Marques
fracmarq@ci.uc.pt

Qualification Requirements and Regulations

Not applicable

Study Programme

Pharmacovigilance and Risk Assessment

Academic year
2012-2013

Course Type
Non Degree Course

Qualification Awarded: Diploma/Certificate

Duration: 30 HORAS

ECTS Credits: 3.0


Applications

Call for Applications (only in portuguese)