Research Unit in Pharmacovigilance and Pharmacoepidemiology
The Research Unit in Pharmacovigilance and Pharmacoepidemiology was established within the Department of Neuroscience, Psychology, Drug Research and Child Health (NEUROFARBA) with the aim of promoting research, education and innovation in the field of drug, vaccine and natural product safety.
The Unit focuses on the study of the benefit/risk profile of pharmacological treatments, through pharmacovigilance and pharmacoepidemiology approaches applied to both clinical practice and scientific research.
Pharmacovigilance deals with the continuous monitoring of medicines after they have been placed on the market, with the aim of identifying, assessing and preventing adverse drug reactions (ADRs). Pharmacoepidemiology studies the use of medicines in the population and analyses effectiveness, safety and prescribing appropriateness through observational studies and epidemiological analyses.
The Unit represents a reference point for interdisciplinary research and advanced training, thanks to the collaboration of pharmacological, clinical, epidemiological and IT expertise.
Research areas
The Unit’s activities include:
- study of the pharmacodynamic and pharmacokinetic mechanisms involved in adverse drug reactions;
- assessment of drug safety in the general population and in more vulnerable groups, such as children, older adults, pregnant and breastfeeding women;
- safety monitoring in clinical trials;
- studies on the effectiveness and safety of complementary medicines and natural products;
- analysis of prescribing appropriateness;
- drug utilisation and consumption studies;
- development of digital tools and IT systems for the management of pharmacovigilance data;
- teaching and continuing education activities aimed at students and healthcare professionals.
Natural products
An important part of the Unit’s activities is also dedicated to the safety of natural products, including:
- herbal medicines;
- food supplements;
- vitamins and minerals;
- homeopathic preparations.
In this area, the Unit conducts epidemiological studies and experimental laboratory activities aimed at understanding the mechanisms involved in adverse effects and interactions with medicines.
Ongoing projects and activities
The Unit is actively involved in research, information and scientific dissemination projects at regional and national level, with particular attention to accurate and accessible communication on medicines and health.
COSIsiFA – Citizens and Healthcare Professionals Always Informed About Medicines
COSIsiFA is an information and training project funded by AIFA, established with the aim of creating a national network among Regions, institutions and public bodies to promote clear, accessible and transparent communication on medicines.
The project is aimed at:
- citizens and patients;
- healthcare professionals;
- associations and local organisations.
The Research Unit participates in the working group dedicated to the dissemination of scientific information, focusing in particular on the design and management of digital and social media content. Through the project’s Instagram, Facebook and LinkedIn channels, evidence-based educational content is published to make complex topics more understandable, reliable and suited to digital communication languages.
ADVANCE and PERSONA projects
ADVANCE (ADVerse reactions to drugs and vaccines, perinatal heAlth and womeN's soCial wEllbeing) and PERSONA (PrEscRiption and Safety of chrOnic drug treatments during pregNAncy) aim to improve knowledge on the use of medicines and vaccines during pregnancy and breastfeeding, in order to assess and, where possible, prevent toxicity risks and risks related to the possible exposure of mothers and newborns to prescribed medicines, vaccines and natural products.
The overall objective is to study exposure to medicines and vaccines and the related adverse reactions, assessing their impact on perinatal psychophysical health and on the social wellbeing of pregnant women and women in the post-partum period, also with reference, at least in the initial phase of the project, to the effects of the COVID-19 emergency.
Collaborations and integrated activities
The Unit works in close collaboration with several regional and academic institutions, including:
- Regional Pharmacovigilance Centre (CRFV) of the Tuscany Region – The Research Unit serves as the Second-Level Pharmacovigilance Centre of the Tuscany Region, for which Prof. Alfredo Vannacci is the University Representative. In collaboration with the CRFV, the Unit coordinates and carries out regional and multi-regional pharmacovigilance projects funded by AIFA, participates in the routine management of reporting forms relating to the Region, and contributes to training and information activities for patients and citizens promoted by the Regional Centre.
- Joint Laboratory for Perinatal Research (PeaRL) – The University of Florence joint research laboratory dedicated to the study of perinatal health and the first thousand days of life promotes interdisciplinary activities that integrate clinical, epidemiological and pharmacological research to improve maternal and child health. The Unit collaborates with PeaRL in the conduct of epidemiological and drug utilisation studies in pregnant and breastfeeding women, contributing to the development of research projects aimed at improving prescribing appropriateness, the safety of pharmacological treatments and health outcomes in the maternal and child health field.
- Regional Health Agency (ARS) of Tuscany – ARS Tuscany is the research and technical-scientific support body of the Tuscany Region, dealing with epidemiological monitoring, evaluation of healthcare services and analysis of regional health data, with the aim of supporting public health decisions and improving the quality of care. At the request of the Tuscany Region, the Unit collaborates with ARS Tuscany in the conduct of epidemiological and drug utilisation research based on regional health data, aimed at promoting a more appropriate, effective and safe use of medicines.
- SOD Medical Toxicology and Poison Control Centre of Careggi University Hospital – The SOD is a regional reference centre for the management of acute and chronic poisoning, perinatal toxicology and the treatment of disorders related to substance use, integrating clinical, care and scientific activities. The Unit collaborates with the SOD Medical Toxicology and Poison Control Centre in the design and conduct of observational studies, contributing to research projects aimed at improving knowledge on the use of antidotal treatments, the treatment of addictions and substance use disorders, and the safety of medicines during pregnancy in clinical practice.
These collaborations make it possible to integrate clinical research, data management and technological innovation within a single operational framework.
Scientific coordinator
- Prof. Alfredo Vannacci
Team
- Prof. Alfredo Vannacci, Associate Professor
- Dr Giada Crescioli, Research Fellow
- Roberto Bonaiuti, Computer Engineer and Technical IT Officer
- Dr Costanza Cacini, Research Fellow
Last update
21.05.2026