Building an ecosystem for better monitoring and communicating of medication safety in pregnancy and breastfeeding


ConcePTION a private public partnership funded by the Innovative Medicines Initiative. It aims to establish a trusted ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate and disseminate reliable evidence-based information regarding effects of medications used during pregnancy and breastfeeding to women and their healthcare providers. This will be achieved by generating, cataloguing, linking, collecting and analyzing data from pharmacovigilance, modelling, routine healthcare, breastmilk samples through a large network. BIPS is involved in two of the eight work packages (WP), WP 1 and WP7.

Objectives of WP 1 are
• To identify the data sources that can be used for medication utilization and medication safety studies in pregnancy;
• To define a standard core set of clinically relevant maternal, perinatal and childhood outcomes;
• To validate specific maternal, perinatal and childhood outcomes;
• To assess the variations in background incidence/prevalence of adverse maternal, perinatal and childhood outcomes;
• To conduct medication utilization studies for newly approved medications to establish the most appropriate strategy and innovative methodologies in population databases;
• To conduct medication utilization studies for selected medications and/or medication classes in pregnant women and women of childbearing age to test the feasibility and validity of innovative approaches, increase population coverage, and inform pregnancy outcome studies;
• To design innovative methodologies to assess the impact of selected medications (classes) used during pregnancy on maternal, perinatal and childhood outcomes and implement these in demonstration projects; and
• To develop methodological guidelines and recommendations for best practice to efficiently generate evidence on use and outcomes of medications in pregnancy based on secondary use of health data;

Objectives of WP 7 (in which BIPS is involved) are
• To create a FAIR data source catalogue, allowing to find adequate data sources, negotiate and assess whether they would be fit for purpose;
• To create common data models for distributed analysis and characterize the quality of potential data sources in collaboration with WP1 and WP2;
• To transfer GePaRD in the common data model for distributed analysis;
• To characterize GePaRD and assess the quality of data;
• To quantify the impact of using different algorithms in WP1 and 2;

Funding period

Begin:   January 2020
End:   March 2024


  • European Union


Dr. rer. medic. Tania Schink

Project management (national)

Miriam Sturkenboom, Utrecht University Medical Center, Netherlands