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.


Studying medicine safety in breastfeeding requires both clinical and non-clinical approaches. Our efforts include analysing how common medicines like antibiotics transfer to milk in in vivo models. A ConcePTION project publication in Journal of Pharmacological and Toxicological Methods reports on a sensitive and rapid method for estimating the concentration of amoxicillin - a commonly used antibiotic - in plasma and milk. | READ MORE >>
There is still a lot of uncertainty about the effects of most medicines on the unborn child. A paper published in BMC Medical Ethics calls for a paradigm shift in the way we generate knowledge on the effects of medicines in pregnancy, paving the way for a learning health care system.  | READ MORE >>
Building evidence for medicine safety in pregnancy requires large sets of high quality data, but until now there were no tools available for grading pregnancy pharmacovigilance data. One of the challenges lies in the fact that a lot of pregnancy pharmacovigilance information is collected in individual case reports, not designed for drug use during pregnancy. The ConcePTION project has developed a four-step process to assess the quality of the information in case reports, listing the elements that are essential for assessing the quality of information used to evaluate the risks associated with medicinal products used during pregnancy.  | READ MORE >>

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Want to know more about ConcePTION's quality management structure for biobanking and pre-analytical handling of human breast milk specimens in the European Breast Milk Collection? Take a look at our report 👇

Interested in the advantages and limitations of the current state-of-the-art for in vivo lactation studies? Take a look at our report 👇

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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.