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.


The ConcePTION ecosystem uses real-world data to generate real-world evidence about medicine safety for women of childbearing age, women who are pregnant or breastfeeding, and their children. Researchers in the project have developed on open-source tool to assess quality of real-world health data. By evaluating the quality of health data obtained outside of clinical trials, INSIGHT can help assess whether data sources can be used reliably for generation of evidence about outcomes. | READ MORE >>
ConcePTION has spent 5 years working to set up an ecosystem for pharmacovigilance in pregnancy and breastfeeding. LIFESAVER is just getting started on their journey towards advancing risk assessment for drugs and chemicals in pregnancy. Together, we work to fill the knowledge gaps. On 14 May, we share what we do, and how we complement each other in a joint webinar.  | READ MORE >>
We don’t know enough about the safety of medicines during pregnancy. Pregnant people are usually left out of clinical trials. A learning healthcare system would allow real-life data from the healthcare system to be used for research – helping to fill this knowledge gap. Marieke Hollestelle, one of the PhD students who have been working in the ConcePTION project, defended her thesis on 16 April.  | READ MORE >>

Twitter / X

the availability of physiological data in infants for PBPK modelling can be improved by systematic searches, as the physiology of a breastfed is different from a formula fed infant. Relevant for lactation-related drug exposure. https://www.mdpi.com/1999-4923/15/11/2618. IMI Conception.

JUST PUBLISHED: Challenges Related to Acquisition of Physiological Data for Physiologically Based Pharmacokinetic (PBPK) Models in Postpartum, Lactating Women and Breastfed Infants—A Contribution from the ConcePTION Project 👇

Connect with us!

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.