PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY
FARMACOVIGILANZA E FARMACOEPIDEMIOLOGIA
| A.Y. | Credits |
|---|---|
| 2023/2024 | 4 |
| Lecturer | Office hours for students | |
|---|---|---|
| Walter Balduini | Wednesdays and Fridays from 10:00 a.m. to 1:00 p.m. by email or phone appointment |
| Teaching in foreign languages |
|---|
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Course with optional materials in a foreign language
English
This course is entirely taught in Italian. Study materials can be provided in the foreign language and the final exam can be taken in the foreign language. |
Assigned to the Degree Course
| Date | Time | Classroom / Location |
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| Date | Time | Classroom / Location |
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Learning Objectives
The course aims at acquiring the theoretical and methodological principles underlying pharmacoepidemiology and pharmacovigilance.
Program
Objectives and methods in pharmacoepidemiology and pharmacovigilance. The scientific method in pharmacoepidemiology. Statistical inference and biological inference. Types of possible errors in pharmacoepidemiological studies: bias, consistency with existing information, biological plausibility, consistency and strength of the association. Limits of premarketing studies and design of pharmacoepidemiological studies. Analytical, experimental, case-control, prospective and retrospective observational studies, case series, and case reports. Relative risk, odds ratio, attributable risk. Reasons to carry out pharmacoepidemiological studies: regulation, marketing, legal actions, clinical hypotheses. Pharmacovigilance. The limitations of clinical trials and the drug monitoring system. The legislation on pharmacovigilance and phytovigilance. Real-world data in pharmacovigilance and pharmacoepidemiology. Analysis of pharmacoepidemiology studies
Bridging Courses
Hygiene, General Pathology and Medical Terminology, General Pharmacology and Pharmacotherapy I
Learning Achievements (Dublin Descriptors)
Knowledge and understanding. Knowledge of the theoretical and methodological principles underlying pharmacoepidemiology and pharmacovigilance.
Applied knowledge and understanding: to know and understand the relevance of observational and analytical studies on the safety profile of drugs and medical devices; to know the fundamentals of pharmacoepidemiology and evidence-based medicine in the evaluation of drugs and medical devices; to know the susceptibility factors to xenobiotics; to know the pharmacovigilance system and the pharmacist's responsibilities in terms of pharmacovigilance.
Autonomy of judgment: Ability to read and interpret the results of pharmacoepidemiological and pharmacovigilance studies from the scientific literature.
Communication skills: knowing how to communicate with appropriate language the main pharmacoepidemiology and pharmacovigilance issues faced during the course.
Learning skills: Ability to critically analyze pharmacoepidemiological research and pharmacovigilance studies.
Teaching Material
The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it
Supporting Activities
There are no support activities
Teaching, Attendance, Course Books and Assessment
- Teaching
Frontal lesson
- Attendance
Basic knowledge of physiology, pathology, pharmacology, pharmacognosy, and toxicology
- Course books
Didactic and in-depth material presented in class and recommended texts are available on the Moodle platform
- Assessment
Oral examination. The aim is to ascertain whether the student has acquired the basic concepts in the section on Learning Outcomes (Dublin Descriptors). The evaluation criteria are the mastery of knowledge, the degree of articulation of the answers, and the level of mastery in the application of toxicological knowledge. The final mark will be based on the evaluation of the oral examination.
- Disability and Specific Learning Disorders (SLD)
Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.
To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.
Additional Information for Non-Attending Students
- Teaching
Non-attending students are invited to consult the teaching material uploaded on Moodle (slides of the lessons and other teaching material)
- Attendance
Basic knowledge of physiology, pathology, pharmacology and pharmacognosy and toxicology
- Course books
Didactic and in-depth material presented in class and recommended texts are available on the Moodle platform
- Assessment
Oral examination. The aim is to ascertain whether the student has acquired the basic concepts in the section on Learning Outcomes (Dublin Descriptors). The evaluation criteria are the mastery of knowledge, the degree of articulation of the answers, and the level of mastery in the application of toxicological knowledge. The final mark will be based on the evaluation of the oral examination.
- Disability and Specific Learning Disorders (SLD)
Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.
To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.
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