Name of organisation
1) Department/Research groupPharmacology Unit - Veneto Pharmacovigilance Centre
2) Organisation/affiliationUniversity Hospital Verona
Short Name in the inventoryPharmacol UNIVR
Administrative Contact
Title Dr
Last name Ingrasciotta
First name Ylenia
Address line 1Pharmacology Unit
Address line 2Department of Diagnostic and Public Health
Address line 3
CityVerona
Postcode37134
CountryItaly
Phone number (incl. country code)390458124706
Alternative phone number390458027612
Fax number (incl. country code)390458124876
Scientific Contact
Title Professor
Last name Trifirò
First name Gianluca
Address line 1Pharmacology Unit
Address line 2Department of Diagnostic and Public Health
Address line 3
CityVerona
Postcode37134
CountryItaly
Phone number (incl. country code)390458124706
Alternative phone number
Fax number (incl. country code)390458124876
Alternative Scientific Contact
Title Professor
Last name Moretti
First name Ugo
Address line 1Pharmacology Unit
Address line 2Policlinico GB Rossi
Address line 3P.le L.A. Scuro 10
CityVerona
Postcode37134
CountryItaly
Phone number (incl. country code)390458124245
Alternative phone number
Fax number (incl. country code)+390458124876
2. Description
The Centre is also part of the Department of Public Health and Community Medicine, University of Verona. It is responsible for the PV activities in the Veneto Region collaborating with the National Agency (AIFA) in analyzing the Italian spontaneous reporting database. Specific expertise and role are present in signal detection methodologies, drug and reactions terminologies and signal communication and diffusion. We are also Reference Centre for Education and Communication within the WHO Programme for International Drug Monitoring and we publish a pharmacovigilance bulletin, FOCUS Farmacovigilanza, member of the International Society of Drug Bullettins (ISDB).
Moreover, the Centre organizes and participates in national and international pharmacoepidemiological studies including specific issues (e.g. drug induced hepatitis, biologicals and vaccines), development of spontaneous reporting system (e.g. patient reporting), medication errors and is involved in ecopharmacovigilance issue.
3. Category
University based
Hospital based
Government based
4. Available resources
In houseVia Contacts/Network
Epidemiologist/Pharmacoepidemiologist
Yes
No
Statistician
No
Yes
Clinician
No
Yes
Clinical Pharmacologist
Yes
No
Pharmacist
Yes
No
Geneticist/Pharmacogeneticist
No
Yes
IT specialist
Yes
No
Ethics expertise
Yes
No
Legal expertise
No
Yes
Regulatory expertise
Yes
No
5. Therapeutic/disease areas of research in drug safety/risk-benefit performed in the past 5 years
Cardiovascular diseases
Gastrointestinal tract
Geriatrics
Immunological products and vaccines
Liver disease
Neonates
Paediatrics
Pregnancy
Skin disorders
drug interaction
medication errors
ecopharmacovigilance
6. Design of drug safety/risk-benefit studies published in the past 5 years
Cohort Study
Case Control Study
spontaneous reporting database analyses
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)
Between 1500 and 14999
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:
relational DB Oracle, Pentaho
Interactive voice response systems
No
Call centre
No
9. Experience in secondary research and meta-analysis
No
10. Work with existing data resources in the past 3 years
Name of data resourceNo. of studies
Italian SR database7
WHO Vigibase1
FDA-AERS3
11. Registries established by centre
None
12. Experience in collaboration in a study team
Principal Investigator
Collaborating Investigator
13. Current involvement in research networks
Networks registered with ENCePP
EUDRAGENE
PROTECT
Other networks:
Network nameNationalInternationalLink to webpage