Name of organisation
1) Department/Research groupNeurofarba Department
2) Organisation/affiliationUniversity of Florence
Short Name in the inventoryPharmacovigilance Unit of Neurofarba Department
Administrative Contact
Title Dr
Last name Luti
First name Filippo
Address line 1Viale Pieraccini 6
Address line 2
Address line 3
CityFirenze
Postcode50139
CountryItaly
Phone number (incl. country code)+390554271282
Alternative phone number
Fax number (incl. country code)Italia
Scientific Contact
Title Professor
Last name Mugelli
First name Alessandro
Address line 1Viale Pieraccini 6
Address line 2
Address line 3
CityFirenze
Postcode50139
CountryItaly
Phone number (incl. country code)+390554271333
Alternative phone number+390554271264
Fax number (incl. country code)Italia
2. Description
In 2004 a specific regulatory initiative (DGRT 617-2004) created the Tuscan Pharmacovigilance Network which has since then involved the Department of Neurosciences, Psychology, Drug Research and Child Health – Section of Pharmacology and Toxicology with a specific Pharmacovigilance Unit. Neurofarba unit is involved in a process of training of reporters of ADRs through the issuing of a specific system of feed-back information: each reporter receives a document of comment containing pharmacological and pharmacoepidemiological data about the specific reported ADR. A precious archive of about 4.000 feedback documents have been produced during the period 2005-2010. Other activities of the Neurofarba Pharmacovigilance Unit involve clincal trials, data analysis, pharmacogenetics studies and phytovigilance.
3. Category
University based
4. Available resources
In houseVia Contacts/Network
Herbal products expertise
Yes
No
Chinese Traditional Medicine expertise
Yes
No
5. Therapeutic/disease areas of research in drug safety/risk-benefit performed in the past 5 years
Cardiovascular diseases
Eye disorders
Geriatrics
Gynaecology
Immunological products and vaccines
Liver disease
Malignant disease
Paediatrics
Pregnancy
Psychiatry
6. Design of drug safety/risk-benefit studies published in the past 5 years
Cohort Study
Case Control Study
Drug Utilisation
Meta-Analysis
7. Experience in collecting data directly from individual patients/respondents
Number of Studies
Greater than 5
Number of patients/respondents involved in the study(ies)
Less than 150
Between 150 and 1499
Greater than 15000
8. Access to data collection resources
Capacity to conduct face-to-face interviews
Yes
In a clinic
Yes
In the community
Yes
Electronic data capture systems
Yes
System used:
Italian pharmacovigilance network database
Interactive voice response systems
No
Call centre
No