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Training Course in Pharmacovigilance and Risk Assessment

Faculty of Pharmacy

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Academic year

2012-2013

Course Type

Non Degree Course

Qualification Awarded

Diploma/Certificate

Duration

30 HORAS

ECTS Credits

3.0

Course Coordinator(s)

Francisco Jorge Batel Marques (fracmarq@ci.uc.pt)

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.
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.
Mode of Study
Face-to-face
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.

Qualification Requirements and Regulations
Not applicable
Examination Regulations, Assessment and Grading
Final classification is awarded through a final exam quoted between 0 and 20.