Institution identification

PURI

https://redirect.ema.europa.eu/resource/44417

Institution ID

44417

Institution full name and acronym

University Medical Center Utrecht (UMCU)

Institution countries

Netherlands

Type of institution

Educational Institution
Hospital/Clinic/Other health care facility

Institution website

ENCePP partner

Yes
Institution description
The mission of the UMCU Clinical Pharmacy research program is to explain,predict and improve patients’ response to pharmacOtherapeutic treatment using pharmacoepidemiological and clinical pharmacological approaches. The research program finds its inspiration in needs and observations from daily patient care. Within this general scope,the research program focuses on three areas: children (patient group oriented),central nervous system drugs(exposure/drug group oriented),and drug induced illness (outcome oriented,i.e. side effects,toxicology,medication errors). The department of Clinical Pharmacy produces >40 peer reviewed publications per year in the area of pharmacoepidemiology,pharmacovigilence and clinical pharmacology.
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

Contact

Studies conducted by the institution

A non-interventional observational study assessing the safety and tolerability of ACARIZAX® in adults (18-65 years of age) (RELIEF)
A post-authorisation/post-marketing observational study to evaluate the association between exposure to AZD1222 and safety concerns using existing secondary health data sources (COVID-19)
A Real World Evidence prospective cohort study in the management of metastatic colorectal cancer: a clinical and patient perspective (PROMETCO)
ACCESS template protocol for safety of COVID-19 vaccines
ACCESS template protocols for effectiveness of COVID-19 vaccines (ACCESS-effectiveness)
Alofisel-5003: An Observational Post-Marketing Registry on the Effectiveness and Safety of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistulas (INSPIRE)
An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19)
Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines (ACCESS-BGR)
Clinical features of COVID-19 in Pediatric Patients (COPP-study)
Cohort Event Monitoring of safety of COVID-19 vaccines in special populations (pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy, people with prior SARS-CoV-2 infection) (Covid-Vaccine-Monitor CVM)
Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination (ECVM)
CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study
Coverage of COVID-19 vaccines in electronic healthcare databases: a protocol template from the ACCESS project
COVID-19 infections and medicines in pregnancy- the INOSS collaboration (INOSS CONSIGN)
Data characterization of population-based data sources: ConcePTION pipeline
Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International))
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 oral retinoid containing medicinal products: utilization and prescribing trends
Implementation of EU risk minimisation measures for medicinal products in clinical guidelines
Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine
Post-Authorisation Active Surveillance Study of Myocarditis and Pericarditis Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine
Post-Authorisation Safety Study of Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5 in Europe
Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources (CVM Covid19-Vaccine-Monitor-EHR)
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)
Use and Safety of Paxlovid Among Patients with Moderate or Severe Hepatic or Renal Impairment
Use and Safety of Paxlovid During Pregnancy