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.


Traditionally, studies on medicine safety during pregnancy and around the time of conception focus on the mothers. There is a need to explore the safety of paternal drug exposure, and its potential effects on pregnancies. A recent publication in the Pharmacoepidemiology and Drug Safety Journal from the ConcePTION outlines the knowledge gaps.  | READ MORE >>
A learning health system is a system where healthcare and research align, sharing data to accelerate research and improve patients’ access to new treatments through this crossover. A recent ConcePTION publication explores the perspectives of the actors providing access to this data (data access providers). Data access providers shared their own motivation to participate in an learning healthcare system, but also emphasized the need for resources and safeguards, and underlined the importance of alignment between different actors, and a good governance system.  | READ MORE >>
To find out if a drug is safe to use during pregnancy, we need data – pharmacovigilance data to be exact. Pregnancy pharmacovigilance data is collected by different actors, in different ways. This has, historically, made it difficult to conduct large-scale studies with information from multiple sources. As a result of this, and the challenges of studying the effects of medicines on pregnant women and their unborn children in general, there is a lack of evidence-based medicine safety information available to this group of people. ConcePTION is working to amend this. | READ MORE >>

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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 👇

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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.