Institution identification

PURI

https://redirect.ema.europa.eu/resource/26175

Institution ID

26175

Institution full name and acronym

Pharmacoepidemiology and Pharmacovigilance department, Spanish Agency of medicines and medical devices (AEMPS)

Institution countries

Spain

Type of institution

Regulatory Authority
EU Institution/Body/Agency
Not-for-profit

Institution website

ENCePP partner

Yes
Institution description
The Spanish agency of medicines and medical devices (AEMPS) is a public body which belongs to the Ministry of Health. Its main task is to regulate all aspects of human and veterinary medicines,from authorisation to pharmacovigilance,so that marketed medicines have guarantees of efficacy,quality and safety.Regarding pharmacovigilance,the Agency has developed and currently maintains BIFAP,a population based database containing general practitioner’s anonymised clinical records to perform pharmacoepidemiological studies. BIFAP database currently contains clinical records of more than 9 million patients. The AEMPS also is the coordinating centre for the Spontaneous Reporting Scheme in Spain and also administer the database supporting this program (FEDRA).
Institution details
Experience with collecting data directly from individual patients or respondents:
No
Interest in carrying out research that is funded by pharmaceutical companies:
No

Contact

Studies conducted by the institution

ACCESS template protocol for safety of COVID-19 vaccines
Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines (ACCESS-BGR)
Changes in alternative treatments for pain and cough in children after introduction of risk minimisation measures for codeine (Alternatives to codeine)
Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination (ECVM)
Description of the cutaneous manifestations of Covid-19 (COVID-PIEL)
Effectiveness of heterologous and booster Covid-19 vaccination in 5 European countries, using a cohort approach in children and adults with a full primary Covid-19 vaccination regimen (Covid Vaccines Effectiveness (CoVE))
Exposure and coverage to routine schedule vaccines in different EU countries (ADVANCE-POC2)
Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends
Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources (CVM Covid19-Vaccine-Monitor-EHR)
Spanish Registry of treatment efficacy against SARS-CoV-2 COVID-19 (RER-FAR-COVID-19)
Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability (MINERVA)
Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children (benefit study on pertussis vaccination)
The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources
TREATMENT WITH BISMUTE SUBCITRATE IN FRAGILE PATIENTS WITH SARS-CoV-2 INFECTION AND DIARRHEA NOT FITTING FOR TRANSFER TO ACUTE HOSPITAL (COVID-19) (COVID-19 BISMUTE)
USE OF DRUGS ACTING ON RENIN-ANGIOTENSIN SYSTEM (RAS) AND RISK OF COVID-19: A CASE-POPULATION STUDY (SRAA-COVID19)