Unit TOXICOLOGY - PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY

PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY

Code	A000542
Location	PERUGIA
CFU	5
Teacher	Claudia Volpi
Teachers	Claudia Volpi
Hours	48 ore - Claudia Volpi
Learning activities	Affine/integrativa
Area	Attività formative affini o integrative
Sector	BIO/14
Type of study-unit	Obbligatorio (Required)
Language of instruction	Italian
Contents	Preclinical and clinical drug development; phase I-IV clinical trials and post-marketing surveillance. Definition, objectives, and historical development of pharmacovigilance. Adverse drug reactions (ADRs): classification, mechanisms, risk factors, and causality assessment. Active and passive pharmacovigilance; spontaneous ADR reporting and completion of reporting forms. National and international pharmacovigilance systems and major safety databases. Italian and European pharmacovigilance regulations. Principles of vaccinovigilance and vaccine safety monitoring. Basics of cosmetovigilance and surveillance of undesirable effects related to cosmetic products. Role of the pharmacist in the management and communication of drug and health product safety.
Reference texts	Lecture notes and teaching materials provided by the instructor; slides and documents distributed during classes.
Educational objectives	The course provides basic and applied knowledge in pharmacovigilance, with particular focus on the safety of medicines and health products. Students will acquire competencies in the identification, evaluation, and reporting of adverse drug reactions (ADRs), post-marketing surveillance principles, national and European regulations, and pharmacovigilance, vaccinovigilance, and cosmetovigilance systems. At the end of the course, students will be able to understand the role of the pharmacist in promoting the safe and appropriate use of medicines.
Prerequisites	Basic knowledge of pharmacology, pharmacotherapy, and toxicology.
Teaching methods	Lectures supported by slides and teaching materials; discussion of case studies and examples related to drug safety and adverse reaction reporting.
Other information	Attendance is not mandatory but is strongly recommended. Teaching materials used during the course will be made available to students.
Learning verification modality	Learning assessment will consist of an oral examination aimed at evaluating the knowledge of the topics covered during the course, the ability to use appropriate scientific terminology, and the capacity to discuss the main aspects of pharmacovigilance, vaccinovigilance, and cosmetovigilance.
Extended program	Drug development and clinical testing: preclinical and clinical studies, phase I-IV clinical trials, and post-marketing surveillance. Origin and evolution of pharmacovigilance; definitions and objectives. Adverse drug reactions (ADRs): definition, classification, mechanisms, and risk factors. Drug interactions and main methods for causality assessment. Active and passive pharmacovigilance; surveillance systems and drug safety monitoring. Spontaneous ADR reporting: characteristics, limitations, and importance of report quality; completion of ADR reporting forms. Organization of national and international pharmacovigilance systems and major safety databases. Italian and European pharmacovigilance regulations and the role of regulatory authorities. Vaccinovigilance: vaccine safety monitoring, adverse events following immunization, and risk communication. Cosmetovigilance: surveillance of undesirable effects related to cosmetic products and the role of the pharmacist in protecting the safety of health products.
Obiettivi Agenda 2030 per lo sviluppo sostenibile	GOal 3: health and well-being

TOXICOLOGY

Code	50125702
Location	PERUGIA
CFU	5
Teacher	Marco Gargaro
Teachers	Marco Gargaro
Hours	62 ore - Marco Gargaro
Learning activities	Caratterizzante
Area	Discipline biologiche e farmacologiche
Sector	BIO/14
Type of study-unit	Obbligatorio (Required)
Language of instruction	Italian
Contents	The course aims to show the negative aspects related to exposure to xenobiotics and to the administration of drugs in particular. The first part of the course describes the basic principles of toxicology and preclinical toxicology studies, also evaluating the state of the art of new alternative methodologies to the use of animals. In the second clinical part, particular emphasis will be given to the description of ADRs, in particular to the interaction between drugs. During practical exercises, the necessary knowledge will be provided to perform in vitro toxicological tests and carcinogenicity assays at both cellular and molecular levels.
Reference texts	Casarett & Doull Elementi di Tossicologia A cura di Patrizia Hrelia, Giorgio Cantelli Forti Casa Editrice Ambrosiana. e Tossicologia. Principi e applicazione all'uso dei farmaci e dei prodotti della salute. Piera Ghi, Massimo Allegrucci, Antonello Di Paolo. Minerva Medica, 2009.
Educational objectives	To transfer to future pharmacists the basics of toxicological knowledge necessary for the proper use and dispensing of drugs, herbal remedies, and related products.
Prerequisites	General Pharmacology and Pharmacotherapy exams have to be passed.
Teaching methods	Classroom lectures on all topics described in the program held by the instructor. Student participation is encouraged to identify any learning difficulties. Practical exercises.
Other information	Recommended frequency
Learning verification modality	The acquisition of all the described skills will be verified by means of an oral examination. Oral test consists of an interview of about 20 minutes aiming to ascertain the knowledge and understanding level acquired by the student on theoretical and methodological contents as indicated on the program. Students with disabilities and/or DSA are invited to visit the page dedicated to the tools and measures envisaged and to agree in advance what is necessary with the teacher (https://www.unipg.it/disabilita-e -dsa).
Extended program	Principles of toxicology. Areas of toxicology, characteristics of exposure, risk assessment, types of adverse effects. Dose-response relationships, threshold and non-threshold effects, hormesis, essential nutrients. Animal experimentation and alternatives for determining the toxicity of a drug. Classification of toxic effects, dose-effect relationship. Cell damage mechanisms. Fundamental secondary and side effects of drugs. Factors that influence the toxic response: factors related to the toxic, the individual and the contact time. Acute, subacute, subchronic, chronic toxicity, mutagenesis, carcinogenesis. Medicines and pregnancy: how to manage therapy in pregnancy. Teratogenesis: stages of development, developmental genes, main teratogenic substances: thalidomide, DES and alcohol. Controlled clinical trials, meta-analyzes and evidence-based medicine. The placebo effect, the nocebo effect. Classification of ADRs, interactions between drugs, phytotherapeutic drugs and foods. QT prolongation: one of the most serious adverse drug reactions. Substances of abuse: characteristics of the different substances of abuse, transition from compulsive abuse to psychic addiction. Prescription opioid overdose. Practical lessons: Handling immortalized, primary, and organoid cell cultures. MTT toxicity testing. Identification of the minimum toxic dose. Ames test to determine drug carcinogenicity. Test for drug interaction evaluation using luciferase reporter systems.
Obiettivi Agenda 2030 per lo sviluppo sostenibile	Health and wellness