OVERVIEW

The PHARMACOVIGILANCE course takes place in the second semester of the fourth year of the Master Degree Course in Pharmacy and it is a module of the integrated course of Pharmacognosy and Pharmacovigilance. Five CFU are attributed to this teaching.

AIMS AND CONTENT

LEARNING OUTCOMES

The course aims at developing and deepening the most important topics regarding pharmacovigilance, phytovigilance, and cosmetic product and medical device vigilance, vaccine and environmental vigilance. Both the national and international regulatory and organizational aspects will be treated as well as those purely applicative with particular regard to the recognition of adverse reactions, the interaction between drugs and between drugs and herbal products. The teaching will discuss not only the aspects of the pharmacovigilance of the products already on the market but also those undergoing clinical trials.

AIMS AND LEARNING OUTCOMES

The aim of the Pharmacovigilance course is to provide the student with knowledge of the basic concepts of pharmacovigilance, related to international and regulatory and epidemiological methodologies for drug surveillance in the post-marketing phase. Furthermore, students will know the main adverse reactions, their classification and specific aspects, as well as the main risk factors for their occurrence.

Learning skills: students will be able to practically manage the reporting of adverse reactions from drugs and non-drugs, an integral part of the profession of the pharmacist.

Soft skills: through the application of specific activities students could acquire a scientific language appropriate to the discipline, improving their communication and social skills (functional alphabetic competence, and socila skills, and ability to learn to learn - at a basal level).

TEACHING METHODS

The course is organized in 20 face-to-face lessons of 2 hours each. 

A part of the lessons could be carried out using the "flipped classroom" method where the students who will participate, individually or in groups, will have to deepen a topic related to the course and present it to the class in power point presentation mode, followed by discussion and peer evaluation. Moreover, didactic activities for scenarios followed by peer-evaluation could be carried out to strengthen the soft skills.

Finally, during the course, a few hours of in-depth study of local pharmacovigilance by a qualified expert may be carried out.

Therefore, in order to obtain a better understanding of the subject, attendance of the lessons is recommended.

Any Student with documented Specific Learning Disorders (SLD), or with any special needs, shall reach out to the Lecturer(s) and to the dedicated SLD Representative in the Department ( Prof. Luca Raiteri, Luca.Raiteri@unige.it ) before class begins, in order to liaise and arrange the specific learning methods and ensure proper achievement of the learning aims and outcomes. VERY IMPORTANT: any request for compensatory tools and adaptations in the exam MUST be done within 10 working days before the date of the exam according to the instructions that can be found at https://unige.it/disabilita-dsa/comunicazioni

SYLLABUS/CONTENT

The program consists of a general and a special part:

Introduction to Pharmacovigilance: definition, aims and objectives and historical notes
Process of a drug: preclinical development, clinical evaluation of drugs
Observational studies
Definitions and classification of adverse reactions (ADR): definition, classification, incidence, analysis of risk factors, relapses and costs; drug interactions; pharmacokinetic variability; pharmacogenetics.
Active and passive pharmacovigilance
Methods in Pharmacovigilance. National Network, New European Regulation and regulatory authorities
Spontaneous reporting, the reporting form and the Iter of adverse reaction reporting
Risk management plan and post-authorization studies
Pharmacovigilance inspections and pharmaceutical crime
Aspects of pediatric and geriatric pharmacovigilance
Pharmacovigilance in pregnancy
Pharmacovigilance of contrast media
Supervisory device
Phytovigilance
Cosmetovigilance
Pharmacovigilance in veterinary medicine
Vaccinovigilance
LASA / SALA drugs
Ecopharmacovigilance 
Selective ADRs

RECOMMENDED READING/BIBLIOGRAPHY

The teaching material presented in the frontal lessons and available on the web classroom is recommended.

TEACHERS AND EXAM BOARD

Exam Board

TIZIANA BONIFACINO (President)

GUENDALINA OLIVERO

MARCO MILANESE (President Substitute)

CHIARA CERVETTO (Substitute)

ERNESTO FEDELE (Substitute)

MASSIMO GRILLI (Substitute)

ANNA MARIA PITTALUGA (Substitute)

LUCA RAITERI (Substitute)

CAROLA TORAZZA (Substitute)

LESSONS

LESSONS START

Lessons will start according to the didactic calendar available on EasyAcademy.

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The end-of-course exam aims to evaluate the achievement of the didactic objectives.

The exam method is oral and will be held in the presence of the course holder and a commissioner.

ASSESSMENT METHODS

The evaluation of the Pharmacovigilance exam takes into account the level of preparation on the topics covered in the course, the reasoning and correlation skills between them, as well as the adequacy of the language used and the exposure.

Exam schedule

FURTHER INFORMATION

Compulsory preparatory courses:Insegnamenti obbligatori propedeutici
60808 FISIOLOGIA GENERALE (FAR)(LM)
55416 BIOLOGIA VEGETALE (FAR)(LM)
55417 BIOLOGIA ANIMALE (FAR)(LM)
60795 CHIMICA ORGANICA (FAR)(LM)
55413 CHIMICA GENERALE ED INORGANICA (FAR) (LM)
55415 ANATOMIA UMANA (FAR) (LM)
55422 FISICA (FAR) (LM)
80314 BIOCHIMICA E BIOCHIMICA APPLICATA
80327 FARMACOLOGIA E FARMACOTERAPIA (LM FAR)
80324 FARMACOLOGIA GENERALE E TOSSICOLOGIA (C.I.)
95338 ELEMENTI DI MATEMATICA