Links to Studies

Status Official Title Lead Investigator Last Updated
Finalised Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends Professor Olaf Klungel 09/03/2023
Finalised Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines Professor Miriam Sturkenboom 09/01/2023
Finalised ACCESS template protocol for safety of COVID-19 vaccines Professor Miriam Sturkenboom 09/01/2023
Finalised Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination Professor Miriam Sturkenboom 09/01/2023
Finalised Impact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and adherence Dr Olaf Klungel 07/11/2022
Finalised Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: risk awareness and adherence Dr Olaf Klungel 07/11/2022
Finalised Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability Dr Susana Perez-Gutthann 18/10/2022
Finalised Review of studies evaluating the effectiveness of risk minimisation measures assessed by PRAC Dr Helga Gardarsdottir 24/03/2022
Finalised Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU Dr Helga Gardarsdottir 17/03/2022
Finalised The relationship between the month of birth and ADHD treatment Dr Rob Heerdink 07/07/2021
Finalised The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources Dr Ana Ruigomez 07/03/2019
Finalised Use of antidepressants and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design. Dr Helga Gardarsdottir 20/02/2019
Finalised Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish registries with an evaluation of available data from further European data sources. Dr Markus Schuerch 04/04/2016
Finalised The risk of acute liver injury with the use of antibiotics. A replication study in the Utrecht Patient Oriented Database. Dr Marie L. De Bruin 20/03/2015
Ongoing Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources Professor Miriam Sturkenboom 09/01/2023
Ongoing Implementation of EU risk minimisation measures for medicinal products in clinical guidelines Dr Helga Gardarsdottir 23/11/2022
Ongoing Impact of EU label changes and regulatory communication on SARS-CoV-2 adenovirus vector vaccines in context of thrombosis with thrombocytopenia syndrome (TTS): risk awareness and adherence Professor Olaf Klungel 26/10/2022
Ongoing Data source heterogeneity in multi-database pharmacoepidemiologic studies: a scoping review Dr Rosa Gini 20/10/2022
Ongoing CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study Professor Hedvig Nordeng 16/08/2022
Ongoing Utilisation of low-dose rivaroxaban in patients with atherosclerotic cardiovascular disease in the united kingdom and the netherlands Mr Nicholas Hunt 11/07/2022
Ongoing Impact of medicines regulatory interventions in Europe: a systematic review focusing on unintended consequences, data used and methodology Dr Helga Gardarsdottir 22/06/2022
Ongoing Review of PRAC assessed PASS evaluating risk minimisation measures (RMM) Dr Helga Gardarsdottir 07/06/2022
Ongoing CAncer Risk and INsulin analoGues Dr Marie L De Bruin 11/12/2015
Ongoing Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data sources and epidemiological design Ms Marietta Rottenkolber 26/06/2014
Ongoing Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design. Dr Francisco De Abajo 31/03/2014
Ongoing Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of the impact of design/database/population differences on the outcome of the studied association Dr Lamiae Grimaldi 01/08/2013
Planned 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 Dr Elisa Martín Merino 22/12/2022
Planned Concordance between primary and secondary electronic healthcare databases: A multi-database self-controlled case series study Mr Hunt Nicholas 18/10/2022
Planned Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International)) Professor Miriam Sturkenboom 29/09/2022
Planned Drug-drug interactions between dicloxacillin/flucloxacillin and DOACs Professor Anton Pottegård 16/11/2020