WP1
Moving beyond pregnancy registries to enhance our understanding of disease-related pregnancy outcomes, medication use and safety of use during pregnancy
The ConcePTION project: bridging the gap
Up to 90% of women take medication at some stage during pregnancy and breastfeeding. Even though many of those medicines are safe to use, only 3,7% of them are explicitly labelled as safe. 1 in 3 choose to discontinue treatment, with potentially serious consequences to their health. With around 5,000,000 pregnancies in Europe ever year, the number of women who are affected is staggering. Of the available medicines, 71% include no information on use when pregnant, and 83% include no information on use when breastfeeding. Of the women, 25% experience anxiety due to a lack of information about medicines. 52% encounter inconsistencies in the available information, 40% report difficulty understanding what is available, and 20% cannot find any relevant information at all.
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.
News
Oct
14
2024
We believe that access to trusted information about the safety of medicines during pregnancy is a fundamental human right. One that is not currently being met. The ConcePTION project have developed two important resources to help bridge this gap: the MUMS knowledge bank & e-learning for health care professionals. On 10 October 2024, we hosted a webinar on providing trusted information on the use of medicine during pregnancy, presenting these two resources. | READ MORE >>
Oct
07
2024
The IMI ConcePTION project has created a data pipeline for pharmacoepidemiology studies based on real-world data sources. The pipeline can be used to study the use and safety of medicines in pregnancy and lactation, but it is also applicable to a vast range of research questions. A description of the data pipeline is now available on a GitHub wiki. | READ MORE >>
The ConcePTION data pipeline is now available
Oct
07
2024
The IMI ConcePTION project has created a data pipeline for pharmacoepidemiology studies based on real-world data sources. The pipeline can be used to study the use and safety of medicines in pregnancy and lactation, but it is also applicable to a vast range of research questions. The pipeline represents the pathway of data transformations from original data to the figures and tables displaying the results of a study as a sequence of five steps.
A description of the ConcePTION data pipeline is available on a GitHub wiki, along with our Common Data Model documentation; catalogue of data sources; tools to support, extract, transform and load data sources to the ConcePTION Common Data Model; the INSIGHT real world data quality checks; the ConcePTION Pregnancy Algorithm; open-source functions to build and document study scripts; repositories of studies using the ConcePTION pipeline, and published studies based on the ConcePTION pipeline.
Do you want to learn more? Visit the ConcePTION pipeline wiki.
Oct
03
2024
The 23rd ISoP Annual Meeting is held 1-5 October in Montreal, and is exploring global perspectives on pharmacovigilance in the digital age and advance therapeutics. Today, Miriam Sturkenboom, coordinator of the ConcePTION project and professor at University Medical Center Utrecht in Netherlands, will present the ConcePTION project and showcase the learning health care ecosystem created. | READ MORE >>
THE WORK PACKAGES
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.