Name of organisation
1) Department/Research groupDepartment of Experimental Medicine, Section of Pharmacology “Leonardo Donatelli”. Center of Pharmacosurveillance and Pharmacoepidemiology, Faculty of Medicine and Surgery, Second University of Naples, Italy
2) Organisation/affiliationFaculty of Medicine-SUN
Short Name in the inventoryCRF_Campania
Administrative Contact
Title Professor
Last name Rossi
First name Francesco
Address line 1Via Costantinopoli,16
Address line 2
Address line 3
CityNaples
Postcode80138
CountryItaly
Phone number (incl. country code)0390815667603
Alternative phone number
Fax number (incl. country code)
Scientific Contact
Title Professor
Last name Rossi
First name Francesco
Address line 1Via Costantinopoli,16
Address line 2
Address line 3
CityNaples
Postcode80138
CountryItaly
Phone number (incl. country code)0390815667603
Alternative phone number
Fax number (incl. country code)
Alternative Scientific Contact
Title Dr
Last name Capuano
First name Annalisa
Address line 1Via Costantinopoli,16
Address line 2
Address line 3
CityNaples
Postcode80138
CountryItaly
Phone number (incl. country code)0390815667669
Alternative phone number
Fax number (incl. country code)0390815667652
2. Description
The Pharmacovigilance and Pharmacoepidemiology Centre of Seconda Università di Napoli monitors drug use in the general population of Campania Region (about 5,800,000 inhabitants). This work permits to point out infrequently adverse events not reported in randomized clinical trials. This Centre has coordinated and conducted several studies in the field of pharmacovigilance and pharmacoepidemiology (drug utilization studies, adverse drug events in emergency department patients monitoring, in-hospital drug
monitoring studies, adverse drug reactions in paediatric population monitoring, adverse drug reactions in elderly population monitoring).
3. Category
University based
Hospital based
4. Available resources
In houseVia Contacts/Network
5. Therapeutic/disease areas of research in drug safety/risk-benefit performed in the past 5 years
Anaesthesia
Cardiovascular diseases
Immunological products and vaccines
Liver disease
Musculoskeletal and joint diseases
Paediatrics
Poisoning/Overdose
Psychiatry
6. Design of drug safety/risk-benefit studies published in the past 5 years
Case Control Study
Drug Utilisation
7. Experience in collecting data directly from individual patients/respondents
Number of Studies
Less 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
No
Interactive voice response systems
No
Call centre
Yes
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
WHO Adverse Drug Reaction Database1
Italian Pharmacovigilance Adverse Event Spontaneous Reporting System (RNF)1
11. Registries established by centre
Drug RegistryMetilphenidate and Atomoxetine
Disease RegistryADHD
12. Experience in collaboration in a study team
Collaborating Investigator
13. Current involvement in research networks
None