ConcePTION

The ConcepTION project seeks to create a paradigm shift in the way drug safety during pregnancy is studied: Establish a successful and sustainable EU ecosystem, based on open and non-proprietary science, of public and private stakeholders, pregnant women and researchers, to generate and disseminate timely and reliable evidence on medicines on maternal, neonatal and long-term outcomes of drug exposure during pregnancy and lactation; a catalog with fully characterized data sources for rapid selection of appropriate data sources; operational, business, network, reporting and data governance models; quality-assured and proven methodological approaches, analytical tools and data platforms that enable distributed analyses; procedures and tools for the collection of digital data and samples directly from pregnant women; in vitro, in silico and in vivo models for the prediction of drug transfer in human milk; a biobank and analytical network for the quantification of drugs in human milk; and best practice documents endorsed by regulatory agencies and health authorities and a web-based drug information knowledge bank.