EU-funded R&D project
Real world evidence on safe, effective medicines use in pregnancy and lactation
Conception is developing an ecosystem for generating and disseminating real world evidence on the use of medicines in pregnancy and during breastfeeding, the effectiveness and safety of these medicines.
The evidence will be generated through a network of women’s health databases held by consortium partners and third parties, and published for access by women, healthcare providers and other decision makers including medicines regulators. This will be achieved by generating, cataloguing, linking, collecting and analysing data from pharmacovigilance, modelling, routine healthcare, pregnant women and their children through a large network. i~HD is a partner and leads a work package on multi-stakeholder engagement and consensus building on the acceptance of real-world evidence, in particular interacting with medicines regulators such as EMA. It also leads a task on information governance and GDPR compliance. The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Novartis, UMC Utrecht, Ulster University, Uppsala Universitet, BBMRI-ERIC, Alma Mater Studiorum Università Di Bologna, i~HD, KU Leuven, Medicines & Healthcare products Regulatory Agency, Netherlands Pharmacovigilance Centre Lareb, Ars Toscana, Karolinska Institutet, The Newcastle Upon Tyne Hospitals, University of Kwazulu-Natal, University of Oslo, St George’s University of London, Eurohealth, UMCG, Orcion, Inserm, BioNotus, Hôpitaux de Toulouse, Università Degli Studi di Ferrara, Prifysgol Abertawe Swansea University, Université de Genève, EFCCP, The Synergist, Entis, The University of Manchester, Region Stockholm, Elevate, Finnish Institute for Health and Welfare, IFC, FISABIO, Ttopstart, European Medicines Agency, RIVM, Janssen, Sanofi, Takeda, GSK, Lilly, Pfizer, Bristol-Myers Squibb Company, Merck, Novo Nordisk, UCB, Abbvie, Ellegaard, Covance, Teva