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In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project-Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation-with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother-child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population., (© 2021 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Background: Torture survivors typically present with varied and complex symptoms, which may challenge assessment by general practitioners (GPs). This study explored the prevalence of torture and trauma history among immigrants born in non-Western countries presenting to GPs in Denmark and the extent to which GPs ask this population about torture or trauma history., Methods: Based on a self-reported questionnaire among non-western immigrant patients, we used bivariate analyses to determine the prevalence of torture and trauma history and the proportion of patients being asked by their GP about this. Data were analysed using multivariate logistic regression., Results: From 46 GP clinics, 300 questionnaires were finalized by immigrant patients. Twenty-eight percent of the patients had a history of torture. Of these, significantly more were men (70%) than women (29%). About half of the torture survivors (55%) had been asked by their GP about torture history. The odds ratio (OR, 95% confidence interval) for being asked about torture history by the GP was 1.28 (0.46-3.53) among women compared with men. Compared with Southeast Europe, OR for being a torture survivor among male immigrants from Middle East-North African region and South and East Asia was 1.83 (0.81-4.15) and 0.25 (0.08-0.82), respectively., Conclusions: Our results suggest that torture and trauma are widespread among immigrants presenting to GPs. In our study, the GPs had managed to detect half of the torture survivors. A more systematic approach to detection in General Practice is advisable, and more knowledge on how and when to ask is needed., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.)