AIMS AND CONTENT

AIMS AND LEARNING OUTCOMES

The aim of the Pharmacovigilance and Pharmacoepidemiology module is to provide students with the theoretical and operational foundations of the post‑marketing surveillance system for medicines and for products that do not fall under the definition of medicinal products, with particular attention to the functioning of the national system and its interactions with the European and international context. The objective is to offer a broad, up‑to‑date and critical understanding of the field.

The course also covers the fundamentals of pharmacoepidemiology, an essential discipline for understanding how medicines are monitored in the population and how their safety, effectiveness and real‑world impact in clinical practice are assessed.

The module aims to promote a culture of Pharmacovigilance among students of the Master’s Degree Programme in Pharmacy, preparing future pharmacists to play an active role in drug surveillance in both public and private settings. It seeks to improve the quality and quantity of reports of suspected adverse drug reactions by fostering awareness, professional responsibility and critical thinking. In addition, it provides knowledge of epidemiological methodologies applied to drug surveillance.

At the end of the course, students will be able to: i) understand national and European pharmacovigilance regulations, including roles, responsibilities and information flows; ii) understand the epidemiological methodologies used in drug surveillance, including descriptive, analytical and risk‑assessment approaches; iii) understand and manage post‑marketing safety procedures, from data collection to signal evaluation; iv) understand the main mechanisms of drug‑induced harm, the types of adverse reactions and the risk factors that contribute to their occurrence; v) manage reports of suspected adverse drug reactions, from completion to submission in accordance with current procedures; vi) identify and evaluate reliable sources of drug information, including regulatory databases, guidelines and scientific literature; vii) acquire the fundamental concepts and methodologies of pharmacoepidemiology. Regarding soft skills, throughout the course students will develop an appropriate scientific language for the discipline, improving their communication and social abilities (functional and social literacy competence, and basic learning‑to‑learn skills).”

TEACHING METHODS

The module consists of 40 hours of face‑to‑face lectures. Part of the teaching activities may be delivered using a flipped‑classroom approach, in which participating students—individually or in groups—will be required to explore a topic related to the course and present it to the class through a PowerPoint presentation, followed by peer discussion and peer evaluation. In addition, scenario‑based learning activities followed by peer assessment may be carried out to strengthen the acquisition of transversal skills. Finally, during the course, a number of in‑depth sessions on territorial pharmacovigilance may be delivered by a qualified expert.

Attendance is therefore recommended in order to achieve a better understanding of the subject.

Students with officially recognised certifications for Specific Learning Disorders (SLD), disabilities or other educational needs, duly submitted to the University, are invited to contact the instructor and the School/Department disability representative (Prof. Luca Raiteri, Luca.Raiteri@unige.it) at the beginning of the course to agree on any teaching arrangements that, while respecting the learning objectives, take into account individual learning needs. IMPORTANT: requests for exam accommodations MUST be submitted at least 10 working days before the scheduled exam date, following carefully the instructions provided at the link: https://unige.it/disabilita-dsa/comunicazioni.

SYLLABUS/CONTENT

The programme includes:

• Introduction to Pharmacovigilance: definition, aims and objectives, and historical background
• Drug development pathway: preclinical development and clinical evaluation of medicines
• Observational studies
• Definitions and classification of Adverse Drug Reactions (ADRs): definition, classification, incidence, analysis of risk factors, consequences and costs; drug–drug interactions; pharmacokinetic variability; pharmacogenetics
• Active and passive pharmacovigilance
• Methods in Pharmacovigilance: National Network, new European Regulation and regulatory authorities
• Spontaneous reporting, reporting forms, and the workflow of adverse reaction reporting
• Risk management plans and post‑authorisation studies
• Pharmacovigilance inspections and pharmaceutical crime
• Pharmacovigilance in paediatric and geriatric populations
• Pharmacovigilance in pregnancy
• Pharmacovigilance of contrast agents
• Medical device vigilance
• Herbal product vigilance (Phytovigilance)
• Cosmetic product vigilance (Cosmetovigilance)
• Veterinary pharmacovigilance
• Vaccine vigilance (Vaccinovigilance)
• LASA/SALA medicines (Look‑Alike/Sound‑Alike)
• Eco‑pharmacovigilance
• Class‑specific ADRs
• Pharmacoepidemiology: definitions, methods, statistical measures and practical applications
• Advantages and limitations of experimental and observational studies
• Pre‑registration experimental studies of medicines and vaccines, and marketing authorisation procedures
• Concepts of superiority, equivalence and non‑inferiority
• Efficacy and effectiveness

RECOMMENDED READING/BIBLIOGRAPHY

Specific indications regarding the reference bibliography will be provided by the instructor at the beginning of the course

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

The class schedule is available at the following link: https://easyacademy.unige.it/portalestudenti/

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The final examination aims to assess the achievement of the intended learning outcomes. The exam is oral and will be conducted in the presence of the course instructor and an additional committee member.

ASSESSMENT METHODS

The examination assessment will take into account the student’s level of preparation on the topics covered during the lectures, the ability to reason and make connections between concepts, as well as the appropriateness of the language used and the clarity of the presentation.

FURTHER INFORMATION

For any further information not included in the course description, please contact the instructor.