Learning objectives
At the end of the course the student is expected to be able to:
- understand the nature and mechanisms underlying adverse drug effects (ADRs)
- know figures/organisms involved to the national pharmacovigilance system
- know the current pharmacovigilance regulations
- know how to use the knowledge acquired for monitoring the safety of approved drugs
Prerequisites
No one
Course unit content
Fundamentals of Pharmacovigilance, definition of ADR, active and passive pharmacovigilance, the causality assessment, pathogenetic mechanisms predisposing to ADR, intyroductionto MEDDRA terminology, the national legislation of Pharmacovigilance, national and European institutions involved in pharmacovigilance, introduction of vaccinovigilance, pharmacovigilance and clinical trials
Full programme
Historical examples of drug damage • Evolution of regulatory interventions in pharmacovigilance • Relevance of adverse drug reactions (ADRs) • Therapeutic appropriateness and iatrogenic pathologies • Classification, pathogenetic mechanisms, risk factors, epidemiology of ADRs • Drug safety in post-marketing phase • Attribution of causal relationship • Drug safety assessment: descriptive methods • Drug safety assessment: analytical methods • Italian Pharmacovigilance Network and suspected ADR alert card • ADRs of major organs and systems
Bibliography
1) Reazioni avverse a farmaci A.P.Caputi, F De Ponti, L. Pagliaro (Ed.
2009) Raffaello Cortina Editore 2) Cobert's Manual of Drug Safety &
Pharmacovigilance (2nd edition, 2011) Jones and Bartlett Learning
Teaching methods
Frontal oral lesson with slides, used to support the study on the recommended textbook, which will be loaded daily on the Elly platform immediately after the lesson. To download the slides, it will be necessary to enroll in the online course. Slides are considered an integral part of teaching material.
The student at the end of the course, using the acquired knowledge, must demonstrate to have understood and to be able to apply the basic concepts of pharmacovigilance
Assessment methods and criteria
The assessment of the achievement of the objectives set by the course through evaluation of the learning will be performed with a written test structured in:
- six multiple response closed questions (3/30 score for each correct answer);
- three open questions (4/30 score for each correct answer);
The duration of the written test will be 1 hour and the test will be evaluated on a scale of 0-30. Laude is given in the case of achieving the highest score and using mastery of the disciplinary vocabulary in the texts of open questions.
Exam results are published on the Esse3 portal within 3 days of the exam date. Students can view the exam, after appointment with the teacher.
Other information
The teacher of Pharmacovigilance can be found by the students every day for a meeting after contact by e-mail.
2030 agenda goals for sustainable development
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