Name of organisation
1) Department/Research groupPharmakovigilanzzentrum Embryonaltoxikologie
2) Organisation/affiliationCharité-Universitätsmedizin
Short Name in the inventoryEmbryotox Berlin
Administrative Contact
Title Dr
Last name Schaefer
First name Christof
Address line 1Pharmakovigilanzzentrum Embryonaltoxikologie
Address line 2Spandauer Damm 130, Haus 10
Address line 3
CityBerlin
Postcode14050
CountryGermany
Phone number (incl. country code)49-30-30308119
Alternative phone number49-30-30308110
Fax number (incl. country code)49-30-30308122
Scientific Contact
Title Dr
Last name Schaefer
First name Christof
Address line 1Pharmakovigilanzzentrum Embryonaltoxikologie
Address line 2Spandauer Damm 130, Haus 10
Address line 3
CityBerlin
Postcode14050
CountryGermany
Phone number (incl. country code)49-30-30308119
Alternative phone number49-30-30308110
Fax number (incl. country code)49-30-30308122
2. Description
Embryotox Berlin was founded 1988 and provides information on drug risks to health care providers and pregnant women all over Germany. Through the consultation process, mainly via phone and email, all relevant data of the patient are collected by application of a structered questionnaire. Follow-up on pregnancy outcome until the infant's age of at least 6 weeks is recorded after birth. There are about 12,000 information requests per year, approximately 4,000 were followed-up. Patient data are stored in a special pharmacovigilance database adapted to the needs of pregnancy/newborn data. Pregnancy outcome data are evaluated in observational cohort studies using women without suspect drug exposure as controls. Several of these studies were published in peer reviewed journals. Our institute is independent from industry and financed by the city government, the BfArM and the federal health ministry. It belongs to the Charité-Universitätsmedizin since January1, 2012.
3. Category
University 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
Neonates
Pregnancy
drug effects on course of pregnancy and newborn and breast fed infant
6. Design of drug safety/risk-benefit studies published in the past 5 years
Cohort Study
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
8. Access to data collection resources
Capacity to conduct face-to-face interviews
No
Electronic data capture systems
Yes
System used:
VigilanceONE
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
None
11. Registries established by centre
Other Pregnant women with drug exposure
12. Experience in collaboration in a study team
Principal Investigator
Collaborating Investigator
13. Current involvement in research networks
Other networks:
Network nameNationalInternationalLink to webpage