Institution identification

PURI

https://redirect.ema.europa.eu/resource/5467

Institution ID

5467

Institution full name and acronym

Pharmakovigilanzzentrum Embryonaltoxikologie (Embryotox Berlin), Charité-Universitätsmedizin

Institution countries

Germany

Type of institution

Educational Institution

Institution website

ENCePP partner

Yes
Institution 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.
Institution details
Experience with collecting data directly from individual patients or respondents:
Yes
Interest in carrying out research that is funded by pharmaceutical companies:
No

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