Industrial pharmacy

General expected learning outcomes The general objective of the Toxicology and Pharmacovigilance course is to provide the student with the basic scientific and regulatory knowledge that will allow him/her to: 1) assess autonomously the risk associated to use or exposure to xenobiotics, particularly drugs; 2) act to minimize the risk, in agreement with regulations and guidelines. Specific expected learning outcomes 1. Knowledge and understanding Knowledge of xenobiotic mechanisms of toxicity. Comprehension of the relationship betweem chemical properties and structure and mechanisms of toxicity. Knowledge of the factors influencing the variability in the response to a xenobiotic. Knowledge of toxicokinetics and pharmacokinetics; comprehension of their implications and applications in the pharmaceutical field. Knoweldge on the methods of experimental studies. Comprehension of the risk evaluation process and its pharmaceutical applications. Knowledge of the basis of chemical carcinogenesis and developmental toxicity and the methods used for studying them. Knowledge of pharmacovigilance, both acive and passive. 2. Applying knowledge and understanding At the end of the course the student should be able to evaluate the risk associated to the use or exposure to drugs and other xenobiotics, also in relations to the characteristics of exposed subjects, of the substance e the way of exposure. The student should be able to propose the measures adequate to minimize the risk, also taking into account the current rules, aprticularly in the pharmaceutical field. 3. Making judgements During the lessons, the teacher frequently questions the students in order to evaluate the comprehension and the ability to use the knowledge learnt. The students will be confronted many examples of real situations that the students will be asked to evaluate. In the final exam, the student will also have to examine and evaluate concrete cases of toxicological problems in the pharmaceutical field. 4. Communication skills The student must demonstrate the ability to clearly and concisely express their assessment of the cases presented, using scientifically appropriate vocabulary and correct terminology in the regulatory field. 5. Learning skills The course aims to provide the formation giving the student the ability of evaluating critically the sources of information widely available, particularly in the web. During the course, the teacher will illustrate the main sources of reliable information, such as databases and sites of institutional organizations.