Institution identification

PURI

https://redirect.ema.europa.eu/resource/47342

Institution ID

47342

Institution full name and acronym

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Institution countries

Sweden

Type of institution

Educational Institution
Laboratory/Research/Testing facility
Not-for-profit

Institution role

Researcher

Institution website

ENCePP partner

Yes
Institution description
CPE is lead by acting director Caroline Öberg. CPE's steering group includes representatives from academia, government agencies, regulatory authorities, pharmaceutical industry and Stockholm's county council. CPE strives to meet the demands from both national and international stakeholders in society and industry concerning data on drug safety, drug utilization, rational drug use and pharmacogenetics. Sweden has a unique opportunity to meet these demands by using national healthcare databases, bio banks, as well as having high levels of expertise in the fields of epidemiologically, pharmacology and other areas. CPE is mainly focusing on drug safety evaluation using data from the Swedish national registers. We have identified five research areas where we in particular can provide expert competence:
• Chronic diseases and biologics
• CNS and drugs
• Drugs during pregnancy and infancy
• Cardiovascular diseases and drugs
• Cancer and drugs.
Institution details
Experience with collecting data directly from individual patients or respondents:
Yes
Interest in carrying out research that is funded by pharmaceutical companies:
Yes

Contact

Studies conducted by the institution

A multinational active safety surveillance study of crizotinib in Europe and the United States
A non-interventional study to examine patient characteristics and drug utilization patterns in migraine patients treated with prophylactic drugs in Nordic countries
A pharmacoepidemiological study to examine patient characteristics, drug utilization pattern and crude incidence rates of selected outcomes in new users of ticagrelor,clopidogrel and prasugrel in national Swedish registries.
A Population-based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes
A population-based cohort study using an existing database to evaluate the association between latanoprost use and primary malignant ocular melanoma and facial cutaneous melanoma
A Population-based Study of the Safety of Gabapentin Use During Pregnancy
A post-marketing registry-based prospective cohort study of long-term safety of risankizumab in Denmark and Sweden
An Active Safety Surveillance Program To Monitor Selected Events In Patients With Long-Term Voriconazole Use
An Active Surveillance Study to Monitor the Real-World Long-term Safety of Somatrogon Among Paediatric Patients in Europe
An observational cohort study to evaluate the risk of adverse pregnancy outcomes in patients treated with etanercept compared to those not treated with etanercept or other biologics using merged data from Sweden, Denmark and Finland
An Observational Postauthorization Safety Study To Describe The Safety Of Ustekinumab and Other Biologic Treatments in a Cohort of Patients With Ulcerative Colitis or Crohn’s Disease Using Compulsory Swedish Nationwide Healthcare Registers and the Independent Swedish National Quality Register for Inflammatory Bowel Disease (SWIBREG) (Stelara UC/CD PASS (SWIBREK))
Beyond Pooled – Part of the BEYOND study program (Benefit of NOACs study of non-valvular AF patients in nordic countries) (BEYOND Pooled (Denmark, Norway, Sweden))
CAncer Risk and INsulin analoGues (CARING) project
Cilostazol Drug Utilisation Study
Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe
Cohort Study of Long-term Safety of Upadacitinib in the Treatment of Atopic Dermatitis in Denmark and Sweden
Cohort Study of the Incidence of Major Cardiovascular Events in New Adult Users of Lisdexamfetamine and Remote Adult Users of Other ADHD Treatments
Cohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort
CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study
Denosumab Global Safety Assessment in Multiple Observational Databases (20090522)
Drug Utilization Study Evaluating Additional Risk Minimisation Measures for Upadacitinib in the Treatment of Ulcerative Colitis in Europe
EPID Multiple Sclerosis Pregnancy study - Pregnancy outcomes in Multiple Sclerosis populations exposed and unexposed to interferon beta - a register-based study in the Nordic countries
Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions
NN9535-4447 Epidemiological assessment of the risk for pancreatic cancer associated with the use of semaglutide in patients with type 2 diabetes- A cohort study based on Nordic registry data
Nordic Country Patient Registry for Romiplostim (NCPRR): Population-Based Prospective Annual Assessment of Safety of Romiplostim Treatment in Adult Patients with Chronic Idiopathic (Immune) Thrombocytopenic Purpura (ITP) Based on National Health Registry Systems in Denmark, Sweden and Norway (20070797)
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)
Pan European Multi-Database Bladder Cancer Risk Characterisation Study
Pharmacoepidemiological study (Drug Utilization Study) of JAYDESS use in routine clinical practice in Sweden (Jaydess DUS)
POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN SWEDEN
POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN THE NETHERLANDS
Post-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury
Post-authorization Safety Program Using the Swedish National Registers—A Validation Study of Cardiovascular and Neoplasm Events in Users of PharmacologicalTreatments for Overactive Bladder
Post-authorization Safety Study Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder
Post-authorization Safety Study Evaluation of Neoplasm Events in Users of Mirabegron and Other Treatments for Overactive Bladder : Core Common Protocol
Pregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database study (CLEAR)
Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids (JOELLE)
Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids: Protopic JOint European Longitudinal Lymphoma and skin cancer Evaluation (JOELLE) Study
RRA-17425, Risperidone Exposure and the Risk of Osteoporosis-related Fractures – Sweden
Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability (MINERVA)
The BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases
Use of Bone Marrow Biopsies in Patients With Chronic Immune Thrombocytopenia: Predictors For, And Prognosis After – a Nordic Population-based Cohort Study And a Nested Case Control Study