AIMS AND LEARNING OUTCOMES

The aim of the Pharmacovigilance course is to provide the student with knowledge of the basic concepts of pharmacovigilance, related to international and regulatory and epidemiological methodologies for drug surveillance in the post-marketing phase. Furthermore, students will know the main adverse reactions, their classification and specific aspects, as well as the main risk factors for their occurrence.

Learning skills: students will be able to practically manage the reporting of adverse reactions from drugs and non-drugs, an integral part of the profession of the pharmacist.

Communication skills: students will acquire a scientific language appropriate to the discipline.

TEACHING METHODS

The course is organized in 20 face-to-face lessons of 2 hours each. In particular situations of need, the lessons will be held on-line.

SYLLABUS/CONTENT

The program consists of a general and a special part:

Introduction to Pharmacovigilance: definition, aims and objectives and historical notes
Process of a drug: preclinical development, clinical evaluation of drugs
Observational studies
Definitions and classification of adverse reactions (ADR): definition, classification, incidence, analysis of risk factors, relapses and costs; drug interactions; pharmacokinetic variability; pharmacogenetics.
Active and passive pharmacovigilance
Methods in Pharmacovigilance. National Network, New European Regulation and regulatory authorities
Spontaneous reporting, the reporting form and the Iter of adverse reaction reporting
Risk management plan and post-authorization studies
Pharmacovigilance inspections and pharmaceutical crime
Aspects of pediatric and geriatric pharmacovigilance
Pharmacovigilance in pregnancy
Pharmacovigilance of contrast media
Supervisory device
Phytovigilance
Cosmetovigilance
Pharmacovigilance in veterinary medicine
Vaccinovigilance
LASA / SALA drugs
Ecopharmacovigilance