Name of organisation
1) Department/Research groupCentre de Pharmacovigilance
2) Organisation/affiliationACRPV / ENTIS
Short Name in the inventoryCRPV Lyon
Administrative Contact
Title Dr
Last name VIAL
First name Thierry
Address line 1Centre de Pharmacovigilance
Address line 2162 avenue Lacassagne
Address line 3
CityLyon
Postcode69003
CountryFrance
Phone number (incl. country code)33472116997
Alternative phone number33472119393
Fax number (incl. country code)33472116985
Scientific Contact
Title Dr
Last name VIAL
First name Thierry
Address line 1Centre de Pharmacovigilance
Address line 2162 avenue Lacassagne
Address line 3
CityLyon
Postcode69003
CountryFrance
Phone number (incl. country code)33472116997
Alternative phone number33472119393
Fax number (incl. country code)33472116985
2. Description
Our department is located in a University Hospital (Hospices Civils de Lyon, HCL) and belongs to the network ACRPV. It includes a poison control, a pharmacovigilance and an addictovigilance center with a specialization for risk evaluation of drugs in pregnancy/lactation. We are member of ENTIS and participated in various committees and working groups of the French ANSM. We have developed a database (Terappel) dedicated to drugs in pregnancy with the aim to prospectively collect data on the outcome of pregnancy after drug exposure. Terappel is used by 18 French PV centers and contained more than 40,000 requests (83,000 drug exposures) and prospective data on the outcome of pregnancy for more than 20,000 patients that are used for collaborative national or international studies. We also have full access on data of patients hospitalized in HCL (14 hospitals, > 1.3 million days of hospitalisation) with a common electronic medical record and computerized prescriptions.
3. Category
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
Congenital Malformations
Immunosuppression
Liver disease
Neonates
Poisoning/Overdose
Pregnancy
Skin disorders
6. Design of drug safety/risk-benefit studies published in the past 5 years
Cohort 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 150 and 1499
8. Access to data collection resources
Capacity to conduct face-to-face interviews
Yes
In a clinic
No
In the community
Yes
Electronic data capture systems
Yes
System used:
Medical records of patients hospitalized in our Univeristy hospital
Interactive voice response systems
Yes
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
Hospital Discharge3
EFEMERIS2
11. Registries established by centre
Drug RegistryDrugs in pregnancy and lactation
12. Experience in collaboration in a study team
Principal Investigator
Collaborating Investigator
13. Current involvement in research networks
Networks registered with ENCePP
ACRPV
ENTIS