Stefania MARZOCCO | PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY
Stefania MARZOCCO PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY
cod. 0760300034
PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY
| 0760300034 | |
| DIPARTIMENTO DI FARMACIA | |
| EQF7 | |
| PHARMACY | |
| 2025/2026 |
| YEAR OF COURSE 4 | |
| YEAR OF DIDACTIC SYSTEM 2023 | |
| AUTUMN SEMESTER |
| SSD | CFU | HOURS | ACTIVITY | |
|---|---|---|---|---|
| BIO/14 | 6 | 48 | LESSONS |
| Objectives | |
|---|---|
| THE COURSE AIMS TO PROVIDE THE STUDENT WITH THE THEORETICAL AND METHODOLOGICAL KNOWLEDGE OF PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY. THE COURSE INTENDS TO PROVIDE THE STUDENT WITH THE TOOLS USEFUL FOR UNDERSTANDING THE ROLE OF THE PHARMACIST IN THE CONTEXT OF THESE PROBLEMS (ESPECIALLY IN THE SPONTANEOUS REPORTING SYSTEM OF ADVERSE REACTIONS FROM DRUGS, VACCINES, PHYTOTHERAPY, MEDICAL DEVICES AND COSMETICS). AT THE END OF THE COURSE THE STUDENT WILL KNOW: THE THEORETICAL BASES AND THE METHODOLOGIES APPLIED TO PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY INDISPENSABLE TO THE ROLE OF THE PHARMACIST WITHIN THE NATIONAL HEALTH SERVICE; THE CONCEPTS AND METHODOLOGIES USED TO CARRY OUT AND INTERPRET STUDIES AND DATA ON PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY, ESSENTIAL TO THE ROLE OF PHARMACISTS WITHIN THE NATIONAL HEALTH SERVICE. AT THE END OF THE COURSE STUDENTS WILL BE ABLE TO: APPLY PHARMACOVIGILANCE REGULATIONS AND PROCEDURES FOR MANAGING THE SAFETY OF MEDICINES AFTER MARKETING; ASSESS THE ISSUES CONCERNING THE DRUG AFTER ITS PLACING ON THE MARKET, BOTH AT NATIONAL AND EUROPEAN LEVEL; MANAGE REPORTS OF ADVERSE REACTIONS FROM DRUGS, INCLUDING USING DRUG ADVERSE REACTION DATABASES AND IDENTIFYING RELIABLE SOURCES OF DRUG INFORMATION; APPLY THE CONCEPTS AND METHODOLOGIES INHERENT IN PHARMACOEPIDEMIOLOGY STUDIES. |
| Prerequisites | |
|---|---|
| IN ORDER TO UNDERSTAND AND BE ABLE TO APPLY MOST OF THE TOPICS COVERED IN THE COURSE, IT IS NECESSARY TO ACQUIRE THE CONTENTS RELATING TO PHARMACOLOGY AND CHEMOTHERAPY |
| Contents | |
|---|---|
| • INTRODUCTION TO PHARMACOVIGILANCE: DEFINITION, OBJECTIVES AND PLACEMENT WITHIN DRUG TESTING PHASES (2 HOURS) • DRUG PROCESS: PRECLINICAL DEVELOPMENT, CLINICAL EVALUATION AND POST-MARKETING OF DRUGS (2 HOURS) • DEFINITIONS AND CLASSIFICATION OF ADVERSE REACTIONS (ADR): DEFINITION, CLASSIFICATION, CAUSAL LINK; INCIDENCE, ANALYSIS OF RISK FACTORS; DRUG INTERACTIONS; PHARMACOKINETIC VARIABILITY; PHARMACOGENETICS; RATIONAL PRESCRIPTIONS (4 HOURS) • PATHOGENETIC MECHANISMS OF ADVERSE REACTIONS AND PREDISPOSING FACTORS (4 HOURS) • MAIN ADRS IN RELATION TO ORGANS AND SYSTEMS (4 HOURS) • ACTIVE AND PASSIVE PHARMACOVIGILANCE (2 HOURS) • METHODS IN PHARMACOVIGILANCE. PHARMACOVIGILANCE NETWORKS, NATIONAL, EUROPEAN AND INTERNATIONAL PHARMACOVIGILANCE SYSTEMS AND REFERENCE REGULATIONS (2 HOURS) • REPORTING METHODS. SPONTANEOUS REPORTING AND REPORTING FORM (2 HOURS) • CORRECT COMPILATION OF THE REPORTING FORM OF SUSPECTED ADVERSE DRUG REACTIONS AND INCLUSION IN THE NATIONAL PHARMACOVIGILANCE NETWORK. PRESENTATION AND DISCUSSION OF ADVERSE REACTION CASES (4 HOURS) • PHYTOVIGILANCE (2 HOURS) • COSMETOVIGILANCE (2 HOURS) • VACCINOVIGILANCE (2 HOURS) • SUPERVISION OF MEDICAL DEVICES AND PHARMACOVIGILANCE IN VETERINARY MEDICINE (2 HOURS) • PHARMACOEPIDEMIOLOGY: DEFINITIONS, METHODS AND PRACTICAL APPLICATIONS. BASICS OF EVIDENCE BASED MEDICINE (2 HOURS) • ADVANTAGES AND LIMITATIONS OF PRE-MARKETING EXPERIMENTAL AND OBSERVATIONAL STUDIES. EPIDEMIOLOGICAL STUDIES ON THE USE OF DRUGS: THE CONTRIBUTION OF PHARMACOEPIDEMIOLOGY TO THE UNDERSTANDING OF THE RISK/BENEFIT RATIO OF DRUGS (2 HOURS) • REAL WORLD DATA IN PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY. HOW TO READ A SCIENTIFIC ARTICLE (4 HOURS) • ANALYSIS OF PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY STUDIES (4 HOURS) • PHARMACEUTICAL CARE: THE IMPORTANCE OF THE PHARMACIST IN THERAPEUTIC ADHERENCE (2 HOURS) |
| Teaching Methods | |
|---|---|
| THE TEACHING PROVIDES LECTURES FOR 48 HOURS (6CFU), LOCATED IN THE CLASSROOM WITH THE AUXILIARY PROJECTION.THE FREQUENCY OF THE LECTURES IS ESSENTIAL. IN ORDER TO TAKE THE EXAM, THE STUDENT WILL HAVE TO FOLLOW AT LEAST 70% OF THE HOURS PROVIDED FOR TEACHING. THE ATTENDANCE TRACKING WILL BE DONE USING THE UNIVERSITY'S EASYBADGE PLATFORM. |
| Verification of learning | |
|---|---|
| THE ACHIEVEMENT OF THE OBJECTIVES OF TEACHING IS CERTIFIED BY AN EXAMINATION GRADED IN 30/30 AND THE MINIMUM WAS 18/30. THE EXAMINATION WILL BE PROVIDED AS AN ORAL TEST.THE ORAL TEST, ABOUT 20 MINUTES, WILL BE ORGANIZED WITH QUESTIONS AND DISCUSSION ON THE METHODOLOGICAL CONTENTS INDICATED IN THE PROGRAM OF THE COURSE. THE ORAL TEST IS FINALIZED TO ASSESS THE LEVEL OF KNOWLEDGE AND THE UNDERSTANDING REACHED BY THE STUDENT. THE TEST ALSO HAVE THE PURPOSE TO VERIFY THE EXPOSURE CAPABILITY AND THE USE OF AN THE APPROPRIATE TERMINOLOGY BY THE STUDENT. MOREOVER THE ORAL TEST WILL ASSESS THE CAPACITY OF THE AUTONOMOUS ORGANIZATION OF THE EXPOSURE OF THE SAME SUBJECT TO THEORETICAL CONTENT. |
| Texts | |
|---|---|
| THERE ARE MANY TEXTS, BOTH ITALIAN AND FOREIGN, THAT CAN PROVIDE AN EXTENT EQUIVALENT TO EACH OTHER ELEMENTS NECESSARY FOR THE STUDY OF THE TOPICS OF THE COURSE. WE RECOMMEND THE USE OF TEXTS PUBLISHED IN RECENT YEARS. - CAPUTI, DE PONTI, PAGLIARO, “REAZIONI AVVERSE A FARMACI – SOSPETTO E DIAGNOSI” – RAFFAELLO CORTINA EDITORE. -"REAL WORLD EVIDENCE E FARMACI. RAZIONALE, CRITICITÀ E APPLICAZIONI NEL CONTESTO ITALIANO" A CURA DI GIANLUCA TRIFIRÒ, EDIZIONI SEED. - TRISHA GREENHALGH. HOW TO READ A PAPER: THE BASICS OF EVIDENCE-BASED MEDICINE; BMJ BOOKS - MANN’S. PHARMACOVIGILANCE. EDITED BY: ELIZABETH B. ANDREWS, NICHOLAS MOORE EDITORS WILEY-BLACKWELL. THE STUDENT MAY ALSO REFER TO WEBSITES RELATING TO THE COURSE CONTENT: WWW.AGENZIAFARMACO.GOV.IT WWW.FARMACOVIGILANZASIF.ORG WWW.EMA.EUROPA.EU |
| More Information | |
|---|---|
| THE COURSE IS TAUGHT IN ITALIAN THE ATTENDANCE IS MANDATORY LOCATION: DEPARTMENT OF PHARMACY |
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