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PHARMACOVIGILANCE

CODE 80330
ACADEMIC YEAR 2022/2023
CREDITS
  • 5 cfu during the 4th year of 8452 FARMACIA (LM-13) - GENOVA
  • SCIENTIFIC DISCIPLINARY SECTOR BIO/14
    LANGUAGE Italian
    TEACHING LOCATION
  • GENOVA
  • SEMESTER 2° Semester
    MODULES This unit is a module of:
    TEACHING MATERIALS AULAWEB

    AIMS AND CONTENT

    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

    TEACHERS AND EXAM BOARD

    Exam Board

    TIZIANA BONIFACINO (President)

    ERNESTO FEDELE

    MARCO MILANESE (President Substitute)

    ANGELA BISIO (Substitute)

    CHIARA CERVETTO (Substitute)

    MASSIMO GRILLI (Substitute)

    MANUELA MARCOLI (Substitute)

    GUENDALINA OLIVERO (Substitute)

    ANNA MARIA PITTALUGA (Substitute)

    LUCA RAITERI (Substitute)

    LESSONS

    LESSONS START

    Lessons will start according to the didactic calendar available on EasyAcademy.

    Class schedule

    All class schedules are posted on the EasyAcademy portal.

    EXAMS

    EXAM DESCRIPTION

    The end-of-course exam aims to evaluate the achievement of the didactic objectives.
    
    The exam method is oral and will be held in the presence of the course holder and a commissioner.

    ASSESSMENT METHODS

    The evaluation of the Pharmacovigilance exam takes into account the level of preparation on the topics covered in the course, the reasoning and correlation skills between them, as well as the adequacy of the language used and the exposure.

    Exam schedule

    Date Time Location Type Notes

    FURTHER INFORMATION

    Compulsory preparatory courses:Insegnamenti obbligatori propedeutici
    60808 FISIOLOGIA GENERALE (FAR)(LM)
    55416 BIOLOGIA VEGETALE (FAR)(LM)
    55417 BIOLOGIA ANIMALE (FAR)(LM)
    60795 CHIMICA ORGANICA (FAR)(LM)
    55413 CHIMICA GENERALE ED INORGANICA (FAR) (LM)
    55415 ANATOMIA UMANA (FAR) (LM)
    55422 FISICA (FAR) (LM)
    80314 BIOCHIMICA E BIOCHIMICA APPLICATA
    80327 FARMACOLOGIA E FARMACOTERAPIA (LM FAR)
    80324 FARMACOLOGIA GENERALE E TOSSICOLOGIA (C.I.)
    95338 ELEMENTI DI MATEMATICA