About ConcePTION

ConcePTION is a project funded by the Innovative Medicines Initiative, a private public partnership. The project was launched in April 2019.

We believe that we have an important societal obligation to radically and rapidly reduce uncertainty about the effects of medication used during pregnancy and breastfeeding to benefit women in making informed decisions about medications used before, during and after pregnancy.

Reporting medicine use in pregnancy

Did you use any medicines when you were pregnant? Here is how you and your health care provider can report what we call an exposure.

Ten principles for stakeholder engagement in the ConcePTION project

The ConcePTION project is building much-needed knowledge for women and health care professionals. To achieve our goal of building an ecosystem for medicine safety in pregnancy and breastfeeding, we need to engage with women, their partners, their doctors, pharmacists, midwives and nurses, the companies that develop medicines and the authorities that approve them and decide what becomes available to patients. Our goal is to work in an open and inclusive way, with the spirit of mutual respect and trust. Here is how we engage with stakeholders in an ethical way.


We have seen that Covid-19 vaccine hesitancy among pregnant women puts mothers and babies at risk. The authors of a recent BMJ editorial argues that pregnant women should be included in drug and vaccine development from the onset, proposing routes that can bring about change. We agree that evidence is lacking, and believe that the ConcePTION project will contribute to bringing about this change by developing a framework for medicine safety in pregnancy and breastfeeding.  | READ MORE >>
We know that there are short- and long-term benefits of breastfeeding for both mothers and infants. But robust clinical lactation studies are rare, and the existing data cannot be confidently translated into evidence-based clinical practice. To provide evidence for how a medicine transfers to breastmilk, we need to test milk from mothers who use medicines during the post-partum period. ConcePTION is developing a research infrastructure to collect, store and analyse samples of breast milk and blood. This infrastructure is compliant with regulatory quality and ISO standards, and will be a platform for lactation studies for both universities and pharmaceutical companies. Helping to bridge the knowledge gap for women who want to breastfeed. | READ MORE >>
European pharmacoepidemiologic data on medicines in pregnancy is collected in different ways in different parts of Europe. To understand the effects of medicine use in pregnancy, we need to find a way to describe and better understand data sources. We also need a model that can handle the differences, without losing the details. ConcePTION has designed a tailored data model that can capture and preserve the granularity of data from different sources in Europe. This common data model is efficient, transparent, comes at a low cost and is ready for use in studies. | READ MORE >>


The ConcePTION consortium

The project unites an unprecedented 88 organizations from 22 countries, including the European Medicines Agency, drug manufacturers, academia, public health organizations, and teratology networks to innovate new solutions to a decades-long public health issue.


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 programme and EFPIA.