First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Medicine
Course unit
FAO2044609, A.A. 2018/19

Information concerning the students who enrolled in A.Y. 2015/16

Information on the course unit
Degree course 5 years single cycle degree in
PHARMACY (Ord. 2009)
FA1732, Degree course structure A.Y. 2009/10, A.Y. 2018/19
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Number of ECTS credits allocated 9.0
Type of assessment Mark
Course unit English denomination TOXICOLOGY AND PHARMACOVIGILANCE
Department of reference Department of Pharmaceutical and Pharmacological Sciences
Mandatory attendance No
Language of instruction Italian
Single Course unit The Course unit can be attended under the option Single Course unit attendance
Optional Course unit The Course unit can be chosen as Optional Course unit


ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Core courses BIO/14 Pharmacology 9.0

Course unit organization
Period Second semester
Year 4th Year
Teaching method frontal

Type of hours Credits Teaching
Hours of
Individual study
Lecture 9.0 72 153.0 No turn

Start of activities 25/02/2019
End of activities 14/06/2019
Show course schedule 2019/20 Reg.2018 course timetable

Examination board
Board From To Members of the board
7 Commissione a.a. 2019/20 02/12/2019 30/09/2020 COLUCCI ROCCHINA LUCIA (Presidente)
MONTOPOLI MONICA (Membro Effettivo)
6 Commissione a.a. 2018/19 03/12/2018 30/09/2019 COLUCCI ROCCHINA LUCIA (Presidente)
MONTOPOLI MONICA (Membro Effettivo)
5 Commissione a.a. 2017/18 01/12/2017 27/11/2018 COLUCCI ROCCHINA LUCIA (Presidente)
MONTOPOLI MONICA (Membro Effettivo)

Prerequisites: Basic Knowledge of Anatomy, Physiology, Biochemistry, Pathology and Pharmacology
Target skills and knowledge: 1) to focus on risk-related issues due to exposure to chemical, physical and biological agents.
2) to understand the importance of experimental procedures to identify toxicity or potential adverse reactions from xenobiotics and drugs and know the main mechanisms involved in cellular and organ toxicity.
3) to know the susceptibility factors including genetic predisposition.
4) to know the prevention and precautionary measures for exposure to potentially hazardous/toxic substances in the workplace.
5) to know the responsibilities of the pharmacist related to the subject of Pharmacovigilance.
6) to acquire the ability to monitor drug safety and provide adequate information for proper use of drugs.
7) to know how to consult the main databases on toxicology and pharmacovigilance for a continuous update of the profession
Examination methods: Written evaluations consisting of open-ended questions and multiple choice questions related to topics covered during the course.
Assessment criteria: Through the use of open-ended questions will be evaluated the ability of the student to expose in a concise but also relevant, general topics through the use of appropriate terminology, to organize a structured speech on a particular topic by referring to examples relevant to the question and to link with related topics. Multiple choice questions will allow you to evaluate the understanding of various topics covered in class.
Course unit contents: Toxicology: historical background. International Regulatory Authorities in the field of health and protection against toxicological risk. Principles of toxicokinetics, absorption, lipid/water partition coefficient, distribution, biotransformation, elimination, half-life, accumulation. Risk factors and individual susceptibility. Toxicology at different stages of drug development (preclinical testing). Identification of useful parameters to classify the toxicity for single administration and for repeated administration. LD50; NOAEL, LOAEL. Therapeutic drug index and exposure limits of potentially toxic agents in food, water, air: IT, MS, ADI, TLV. Methodological aspects to identify the carcinogenic potential. Reproductive and developmental toxicity, methodologies and classes of risk for exposure to toxic agents during pregnancy. Classification of hazard and toxicity of chemical agents for humans and the environment and labeling standards. Occupational toxicology and health surveillance. Biotransformations, reactive intermediates, induction and enzymatic inhibition: toxicological relevance for xenobiotics, drugs and drug interactions. The genetic polymorphism in efficacy and adverse drug reactions. Cellular mechanisms of toxicity. Ionic alterations. Radical species of oxygen and nitrogen (ROS and NOS) and scavengers. Necrosis and apoptosis. Toxins. Carcinogenesis. Main mechanisms of organ toxicity from drugs and xenobiotics: pulmonary, cutaneous, hepatic, renal, cardiovascular, endocrine, immune. Toxicity of the nervous system, dependence on drugs and substances of abuse, doping.

Pharmacovigilance: historical background, thalidomide, definitions. Classification of adverse drug reactions (ADR): type, incidence, severity, causal link. Eudravigilance and National Network of Pharmacovigilance (RNF). Reporting card for suspected adverse drug reaction, computerized reporting system. Drug safety in pre-registrative stages, pre-clinical studies, phase I, II, III. Experimental protocol, sample selection, randomization, placebo, blinded studies, distortion factors, multicentre studies. Ethics committees. Signal analysis, identification, databases, descriptive and analytical observational studies. Cohort studies, case-control. Guidelines for the insertion of drugs in the therapeutic handbook. AIFA notes. Use "off label" of drugs. Risk/ benefit ratio of a drug. Children, elderly, polypharmacy. Adherence to therapy. Clinical risk. Phytovigilance. Adverse reactions phytoterapic products, interactions between conventional and phytoterapeutic drugs.and precautionary measures. Examples of adverse drug reactions and precautionary measures. Main regulatory Authorities and regulations on Pharmacovigilance. WHO, EMEA, AIFA, ISS.
Planned learning activities and teaching methods: The lecturer will have a lectures on the main topics in the field of Toxicology and Pharmacovigilance. Seminar activities are planned with references to practical experiences. Use of computer rooms to simulate the use of useful databases in the toxicological or pharmacovigilance fields. Pharmacists working in public health facilities (hospital pharmacy, pharmaceutical sector) and researchers in pharmaceutical companies and/or experts in toxicological matters will be invited.
Additional notes about suggested reading: The course material will be made available on Moodle platform. For further information, during the course will be provided scientific publications and suggested links and databases accessible on the web.
Textbooks (and optional supplementary readings)
  • Casarett & Doull, ELEMENTI DI TOSSICOLOGIA. Milano: Casa editrice Ambrosiana, 2013. Cerca nel catalogo
  • Galli, Corsini, Marinovich, TOSSICOLOGIA. Padova: Piccin, 2016. Cerca nel catalogo
  • Balduini, Costa, TOSSICOLOGIA generale e applicata ai farmaci. Milano: Edra, 2015. Cerca nel catalogo
  • Ghi, TOSSICOLOGIA. Torino: Minerva Medica, 2009. Cerca nel catalogo

Innovative teaching methods: Teaching and learning strategies
  • Lecturing
  • Problem based learning
  • Case study
  • Working in group
  • Questioning
  • Story telling
  • Problem solving
  • Active quizzes for Concept Verification Tests and class discussions
  • Loading of files and pages (web pages, Moodle, ...)
  • Learning journal

Innovative teaching methods: Software or applications used
  • Moodle (files, quizzes, workshops, ...)

Sustainable Development Goals (SDGs)
Good Health and Well-Being Quality Education Clean Water and Sanitation Industry, Innovation and Infrastructure Responsible Consumption and Production Life Below Water Life on Land