From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Nicolas Thurin, Romin Pajouheshnia, Giuseppe Roberto, Caitlin Dodd, Giulia Hyeraci, Claudia Bartolini, Olga Paoletti, Hedvig Nordeng, Helle Wallach- Kildemoes, Vera Ehrenstein, Elena Dudukina, Thomas MacDonald, Giorgia De Paoli, Maria Loane, Christine Damase-Michel, Anna-Belle Beau, Cécile Droz-Perroteau, Régis Lassalle, Jorieke Bergman, Karin SwartTania Schink, Clara Cavero-Carbonell, Laia Barrachina-Bonet, Ainhoa Gomez-Lumbreras, Maria Giner-Soriano, María Aragón, Amanda Neville, Aurora Puccini, Anna Pierini, Valentina Ientile, Gianluca Trifirò, Anke Rissmann, Maarit Leinonen, Visa Martikainen, Sue Jordan, Daniel Thayer, Ieuan Scanlon, Mary Georgiou, Marianne Cunnington, Morris Swertz, Miriam Sturkenboom, Rosa Gini

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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.

Original languageEnglish
Pages (from-to)321-331
Number of pages11
JournalClinical Pharmacology and Therapeutics
Issue number1
Early online date26 Nov 2021
Publication statusPublished (in print/issue) - 1 Jan 2022

Bibliographical note

The ConcePTION project has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking under grant agreement No.
821520. This Joint Undertaking receives support from the European
Union’s Horizon 2020 research and innovation program and EFPIA.

© 2021 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.


  • Pregnancy
  • pharmacoepidemiology
  • Phase IV
  • Bioinformatics
  • Pharmacology (medical)
  • Pharmacology


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