PHARMACOVIGILANCE AND TOXICOLOGY

Course objectives

PHARMACOVIGILANCE Il corso ha l’obiettivo di fornire allo studente le conoscenze necessarie relative agli obiettivi della Farmacovigilanza, in particolare la valutazione del rischio connesso all’assunzione dei farmaci e la stima dell’incidenza delle loro reazioni avverse. Attraverso lo studio dell’organizzazione del Sistema di Farmacovigilanza, lo studente comprenderà come tali obiettivi siano raggiungibili attraverso i seguenti passaggi fondamentali: 1) individuare il più rapidamente possibile nuove reazioni avverse da farmaci (ADR); 2) migliorare ed allargare le informazioni su ADR sospette o già note; 3) valutare i vantaggi di un farmaco su altri o su altri tipi di terapia; 4) disseminare tali informazioni per rendere più corretta e adeguata la pratica clinica terapeutica. Tali conoscenze permetteranno allo studente di acquisire capacità professionali specifiche, correlate al monitoraggio di effetti indesiderati associati ad un trattamento farmacologico. Durante il corso, lo studente sarà stimolato a formulare giudizi e ad esercitare il senso critico relativamente alle problematiche studiate. Il corso è articolato in lezioni frontali al fine di consentire l'acquisizione delle conoscenze, di sviluppare le capacità comunicative ed il linguaggio tecnico attraverso l'interazione in aula con il docente su argomenti inerenti al corso e a problematiche correlate. L'approccio critico del corso permetterà allo studente di sviluppare l'autonomia di apprendimento, utile ai fini degli studi successivi o per l'auto-aggiornamento. TOXICOLOGY The course of Toxicology aims to provide students with the qualifying knowledge about the toxicological effects and the mechanism of action of physical and chemical agents on mammals and environment, and about the possible protective/preventive strategies to apply for the toxicity risk management. The student will acquire knowledge about the principles of general toxicology (toxicodynamic, toxicokinetic, mutagenesis, cancerogenesis and teratogenesis), the risk assessment procedures, and about some topics of systemic toxicology, food toxicology and ecotoxicology. This knowledge will allow the student to acquire the suitable professional skills related to environmental, drug, cosmetic and food safety. During the course, the student will be stimulated to critically evaluate the challenges and problems about the topic under study, particularly the toxicity power of some natural compounds whose toxicity risk is often underperceived due to their natural origin or the low exposure levels. The course is based on lectures aimed at developing communication skills and technical language through the classroom interaction with the lecturer about the toxicology and the related challenges. Taking advantage of the lecturer support, the student could explore specific topics of toxicology, through looking up medical and scientific databases, which will be further discussed in the classroom. The course will also allow the student to develop communication skills and autonomy of learning, useful to perform subsequent studies or for the self-updating.

Channel 1
ADELE ROMANO Lecturers' profile

Program - Frequency - Exams

Course program
Part I – Principles of Toxicology Definition, aims, and scope of toxicology. Toxicological risk assessment and dose–response relationship. Individual variability and influencing factors. Toxicokinetics: absorption, distribution, metabolism (Phase I and II), excretion. General mechanisms of toxicity: free radicals, macromolecular interactions, oxidative stress. Basic notions of organ toxicity (liver, kidney, nervous system). 3Rs principle and alternative methods to animal testing. Part II – Pharmacovigilance and Drug Safety WHO definitions of ADRs and adverse events. ADR classification (Rawlins & Thompson, DoTS). Factors influencing ADR susceptibility. Drug interactions (pharmacokinetic and pharmacodynamic). National and international pharmacovigilance systems (AIFA, EMA, WHO). The role of the pharmacist and the medical representative in ADR reporting. Regulatory aspects and quality control in product safety. Basic concepts of epidemiology applied to toxicological and pharmacovigilance data.
Prerequisites
Basic knowledge of chemistry, biochemistry, physiology, and pharmacology is required. Elementary understanding of statistics and experimental methods is recommended.
Frequency
Attendance is optional but strongly recommended
Exam mode
Assessment consists of a single oral examination evaluating theoretical understanding and practical reasoning. Evaluation criteria: Accuracy and completeness of answers Application of knowledge and problem-solving Clarity and technical vocabulary Critical and integrative reasoning Minimum passing grade: 18/30; “30 with honours” for excellent performance.
Lesson mode
Lectures supported by multimedia presentations, case discussions, and short exercises on ADR reporting and toxicological data interpretation. Teaching materials: slides, AIFA/EMA guidelines, WHO documents, and online resources.
  • Lesson code1052170
  • Academic year2025/2026
  • CourseApplied Pharmaceutical Sciences
  • CurriculumINFORMAZIONE SCIENTIFICA SUL FARMACO
  • Year3rd year
  • Semester2nd semester
  • SSDBIO/14
  • CFU9