May
22
2025
Women who choose to stop treatment during pregnancy and breastfeeding are putting their health at risk, and have to weigh their desire to have children and breastfeed against a risk that we know very little about. In two ongoing clinical trials, researchers establish a new standard for human lactation studies that includes sampling of breast milk and plasma from both mothers and breastfed infants. | READ MORE >>
Apr
11
2025
The IMI ConcePTION project has developed a Core Data Elements methodology for studying drug safety during pregnancy, by exploring how data can be standardised and analysed. A recent paper in the Journal of Clinical and Experimental Reproductive Medicine demonstrates the usefulness of this approach. However, the study also highlights the challenges in pregnancy pharmacovigilance and emphasises the need for overall, worldwide accepted standards – for safer medication use during pregnancy. | READ MORE >>
Dec
16
2024
Physiologically based pharmacokinetic (PBPK) models are used to predict the transfer of medications from mother to baby through breast milk. For clinical practice and research, accurate assessment of infant feeding is relevant. The ConcePTION project has developed a mathematical function that improves the estimation of the infant’s intake of breast milk, which is key for estimations of infant exposure to maternal medicines. | READ MORE >>
Dec
12
2024
On 11 December, we hosted the final ConcePTION webinar, together with 110+ live participants. The session was focusing on using real-world data sources for pregnancy pharmacoepidemiology. Rosa Gini presented the ConcePTION pregnancy algorithm and Judit Riera Arnau presented an algorithm to prioritize teratogenic drug safety research. Did you miss the live webinar? Don't worry! The recording is now available. | READ MORE >>
Dec
09
2024
On 21 November, the ConcePTION consortium gathered for our celebratory close-out event in Brussels. During the event, we reflected on our achievements and charted a bold course for the future. At the heart of the event was the unveiling of ConcePTION’s 10-in-10 initiatives: a roadmap to address unmet needs over the next decade. | READ MORE >>
Nov
25
2024
Can we use real-world data to study medicine safety in pregnancy and lactation? Yes, we can! Join us on 11 December between 14:00-15:30 (CET) to learn more about our real-world data pipeline for pharmacoepidemiology studies and how you can use it for a range of research questions. | READ MORE >>
Nov
20
2024
At the end of 2024, the IMI ConcePTION consortium formally disbands after five years of progress to improve medicine safety in pregnancy and breastfeeding. On Thursday 21 November, we are hosting an event in Brussels to mark the end of the project, and plan for the future: presenting 10 proposals for policy that can improve access to accurate and reliable information about medicine safety in the coming ten years! | READ MORE >>
Nov
14
2024
Access to good quality data is essential for assessing medicine safety in pregnancy. The ConcePTION project has developed an app to collect information from expecting mothers in the United Kingdom. The Meds4Mums2B app will allow women in the United Kingdom to both report the medicines they use and receive information on medicine safety through the app. | READ MORE >>
Nov
12
2024
Breastfeeding has a lot of health benefits for both mothers and infants. But there is often limited information on how safe a particular medicine is for infants when taken by their breastfeeding mothers. The ConcePTION project has developed an in vitro model to predict how medicines transfer to breast milk. The results provide data that that can improve in vivo study design. | READ MORE >>
Nov
05
2024
Cetirizine is a medicine that is used to prevent and treat allergy symptoms, such as red, itchy eyes, sneezing, a runny or stuffy nose, or hives. This medicine is recommended for breastfeeding women, which makes it important to study how much of the drug transfers to mother’s milk. The ConcePTION project has developed a new pharmacokinetic (popPK) model to predict the concentrations of cetirizine in human breast milk, and to estimate how much of the medicine that is received by the breastfed infant. | READ MORE >>
Nov
04
2024
This week, ConcePTION is taking part in the #MedSafetyWeek social media campaign together with 107 organisations from 94 countries, to raise awareness of preventing side effects of medicine. Because sometimes pregnant women need to take medicines. And during pregnancy, some effects cannot be assessed until after the child is born. Therefore, it is important that pregnant women report their medicine use regardless of their immediate effects. | READ MORE >>
Nov
01
2024
For ethical reasons, pregnant and breastfeeding women are rarely included in clinical trials. To close the knowledge gap regarding the safety of medicine use during pregnancy and breastfeeding, researchers rely on other sources of information. One of them is electronic healthcare data – sometimes referred to as Real World Data. These data are crucial for understanding health events in populations and making decisions in public health and regulation. A paper recently published in American Journal of Epidemiology suggests a method to improve the validity of studying health events in populations using Real World Data. | READ MORE >>
Oct
29
2024
Gabapentinoids are initially approved to treat epilepsy, but in recent years the use has extended to other conditions. A new systematic review from the ConcePTION project has highlighted potential risks associated with gabapentinoid use during pregnancy, emphasizing possible negative effects on both pregnancies and on the long-term health of newborn children. | READ MORE >>
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 >>
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 >>
Sep
24
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 and e-learning for health care professionals. Join our webinar on 10 October at 14 CEST to learn more about these resources! | READ MORE >>
Sep
02
2024
The ConcePTION project has validated a novel method to evaluate the quality of real-world pregnancy pharmacovigilance data. The validation is based on 186 case reports. The results are published in Drug Safety, and represents an advancement in how data on medication safety during pregnancy is collected and assessed. | READ MORE >>
Aug
23
2024
On 24-28 August, the International Society of Pharmacoepidemiology is organising their 40th annual ISPE Meeting. This year, experts from all across the world are gathering in Berlin, Germany to discuss essential topics in pharmacoepidemiology. Researchers from the ConcePTION project will present and discuss results on pregnancy and infant outcomes and our data-driven approaches. | READ MORE >>
Aug
08
2024
Sertraline is used to manage several mental health conditions, and it is frequently prescribed during pregnancy and breastfeeding. The ConcePTION project has developed a population pharmacokinetic (popPK) model to describe how the body interacts with the drug during pregnancy and breastfeeding. | READ MORE >>
Jul
08
2024
Multiple Sclerosis, often referred to as MS, is an unpredictable disease that affects the central nervous system. The disease can debut at any age, but most often manifests between the ages of 20 and 40 and women are more at risk. Certain forms of MS respond well to a drug called dimethyl fumarate. Because we don’t know enough about how this drug transfers to breastmilk, new mothers who are on this medication often face difficult decisions about breastfeeding. A recent case report published in Frontiers in Public Health shares findings that help fill this knowledge gap – towards a future where women can make informed decisions. | READ MORE >>
Jun
20
2024
Since the launch in 2019, 80 partners representing key stakeholders in the field have worked together to build an ecosystem that can empower pregnant and breastfeeding women to make informed decisions about medicines. On June 13-14, The IMI ConcePTION consortium convened one last time at the historic De Bazel building in Amsterdam to reflect on the advancements and make plans for the last six months of the project. | READ MORE >>
Jun
18
2024
A recent paper published by researchers involved in the ConcePTION project explores the complexities of health information collected in electronic databases, commonly used to study the safety and effectiveness of medicines. Understanding the diverse features of these data sources is crucial for researchers to reproduce studies and validate their results. Something that can help us fill the knowledge gap on medicine safety in pregnancy and breastfeeding. | READ MORE >>
Jun
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. That’s why we’ve developed MUMS (Mothers Using Medicines Safely); a free-to-use, easy-to-understand, publicly accessible bank of reliable information about the use of medicines during pregnancy. The website has been launched in English in June 2024, with translations in Polish and Italian following in the summer of 2024. | READ MORE >>
Jun
03
2024
With 5,000,000 pregnancies each year in Europe alone, there is a pressing need to fill the knowledge gap in medicine safety during pregnancy and breastfeeding. ConcePTION has spent 5 years working to set up an ecosystem for pharmacovigilance in pregnancy and breastfeeding. LifeSaver (Living Impact on Fetal Evolution) 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 2024, we shared what we do and how we complement each other in a joint webinar. | READ MORE >>
May
29
2024
Sodium Valproate is a medication used to control seizures, and it's also been effective in treating bipolar disorder and migraines. Unfortunately, it is also associated with an increased risk of foetal malformation when used by pregnant women. A paper published in Neurotoxicology and Teratology is the largest to explore how the mediation impacts brain, behaviour and social development in children diagnosed with Fetal Valproate Spectrum Disorder – observing difficulties all the way into adulthood. | READ MORE >>
May
23
2024
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 >>
Apr
24
2024
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 >>
Apr
16
2024
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 >>
Apr
12
2024
Women sometimes need medicines. This is true in all stages of life, also after having a baby. Breastfeeding is often encouraged, but we don’t know enough about the amount of medicine being transferred to breastmilk. The UmbrelLACT study will collect data on how a mother’s medicines transfer from her blood to her breastmilk, to what extent the child is exposed to the drug compound in question, and the general health outcome of the child. As part of the ConcePTION project, they have developed a generic study protocol for how to collect this data. | READ MORE >>
Apr
10
2024
ConcePTION’s goal is to give women the opportunity to take informed decisions about their health and treatment also during the vulnerable periods of pregnancy and breastfeeding. This is hard, because these women are often excluded from clinical trials to protect their babies. And to be able to offer sound advice, a lot of data is needed. To be able to explore the safety of medicines during breastfeeding at a scale that provides enough data to fill the knowledge gap, animal models and in vitro studies are necessary. A recent publication outlines why isolated epithelial cells from Göttingen Minipigs are a good fit to create an in vitro model to study the blood milk barrier. | READ MORE >>
Apr
08
2024
Understanding how medicines transfer from a mother to the breastfeeding infant is crucial for women who need to take informed decisions about medical treatment. Right now, we are launching two clinical studies to collect breast milk and blood samples from mothers and infants, to study how two commonly used medicines transfer through milk. This study paves the way for evidence-based recommendations for treating diabetes, rheumatoid arthritis and other diseases during breastfeeding. | READ MORE >>
Mar
15
2024
Learning healthcare systems, where healthcare and research are closely connected, hold promise for addressing knowledge gaps that traditional clinical studies struggle to fill. But despite their potential, few of these systems are currently operational. Due to the resources needed, their implementation often falls to specific projects. To support stakeholders in this endeavour, researchers from the ConcePTION project have developed an ethics framework for transitioning to operational learning healthcare systems, detailed in their recent publication in Learning Health Systems. | READ MORE >>
Feb
15
2024
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 >>
Feb
12
2024
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 >>
Feb
01
2024
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 >>
Jan
19
2024
Drug utilisation studies are used to explore the medical, social and economic effects of the marketing, distribution, prescription and use of a medicine in society. Unlike clinical trials, these studies are performed after a treatment has already been brought to market. In the case of medicine safety in pregnancy and breastfeeding, drug utilisation studies play an important role in filling the knowledge gap, providing a firm foundation for safety studies by contextualising spontaneous reporting of serious adverse events. In a paper recently published in Journal of Pregnancy, the authors outline how these studies should be designed to be useful for this purpose. | READ MORE >>
Dec
14
2023
PBPK modelling is used to predict the concentration of different drug compounds in blood plasma and breastmilk. The method is useful in drug development, as it optimises dosing regimens and gives an idea regarding the safety of the medicine. To do so effectively researchers need data on how different drug compounds move through the body. But we don’t know enough about the physiology of new mothers and their babies. A recent ConcePTION publication highlights the challenges of developing PBPK models for these groups. | READ MORE >>
Nov
08
2023
The ConcePTION Meds4Mums2B [Meds for mums to be] app, developed in partnership with the UK regulatory agency MHRA, will launch in the United Kingdom in spring 2024. It is the first of its kind, and will help share and collect vital safety information about medicine use during pregnancy and breastfeeding. With this dual mission, the app will help change how we approach healthcare for expectant and nursing mothers. | READ MORE >>
Nov
06
2023
From 6 to 12 November, ConcePTION will take part in the global #MedSafetyWeek campaign, a collaboration involving more than 80 medicines regulatory agencies and several non-governmental organisations, to raise awareness about the importance of reporting side effects of medicines. And for pregnant women to report every time they are exposed to a medicine, to help close the knowledge gap in medicine safety for pregnancy and lactation. With the theme ‘Who can report?’, this year’s campaign will focus on the key role of every patient, woman, doctor, nurse, and pharmacist who reports a side effect or exposure and contributes to safe medicine use. | READ MORE >>
Nov
01
2023
There is a growing number of human data catalogues. As the European Health Data Space (EHDS) is developing it vision for a joint European descriptive metadata catalogue to help enable secondary use of the data in these catalogues, the experience of developing the ConcePTION data catalogue can be of great relevance. A recent opinion review shares several recommendations on what is needed to make human data catalogues work better together. | READ MORE >>
Oct
24
2023
Regulators, prescribers and patients are calling for initiatives to fill the knowledge gap about medicines and breastfeeding. The ConcePTION initiative set out to find out how safe medicines are for nursing mothers and their babies. A recent clinical lactation study, conducted within the framework of the ConcePTION project, set out to demonstrate the feasibility of a European collaborative human breast milk study by examining the transfer of a common antihistamine, cetirizine, into breast milk. The results are detailed in a recent publication in Basic & Clinical Pharmacology & Toxicology, that sheds light on the safety of these medications during lactation. | READ MORE >>
Oct
19
2023
Antidepressant medications like fluvoxamine are sometimes prescribed to pregnant and breastfeeding women to manage mental health conditions like depression and anxiety. Understanding the safety and potential risks associated with these medications is crucial to ensure that pregnant and postpartum women receive appropriate treatment for their mental health needs. | READ MORE >>
Oct
17
2023
"Pregnancy and breastfeeding can be a chaotic period, exacerbated by lack of safety information for drugs taken during this time. The IMI ConcePTION project aims to change that." So reads the first paragraph of the Uppsala Monitoring Centre's feature about ConcePTION in Uppsala Reports. Published today, this article describes the ins and outs of the ConcePTION project, and how it's all connected. | READ MORE >>
Oct
10
2023
Breastfeeding is beneficial for both mother and child. New mothers are encouraged to breastfeed for 6 months exclusively and continue to breastfeed while other food sources are introduced until the child is at least two years old. During the postpartum period, many new mothers need medicines. Because of a lack of information on medicine safety for the nursing infant and child, many women choose to stop breastfeeding to protect their babies. But maternal drug intake only rarely requires interruption of breastfeeding. | READ MORE >>
Sep
27
2023
ConcePTION has brought together industry, academic and clinical experts with extensive experience in conducting pregnancy medication safety research. Together, they set out to develop a reference framework describing the core data elements which should be collected in primary source pregnancy medication safety studies. | READ MORE >>
Aug
31
2023
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 >>
Aug
03
2023
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 >>
Jul
14
2023
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 >>
Jun
26
2023
Neurodevelopment is a complex set of functional domains. To assess whether or not brain development is affected by exposure to medicines during pregnancy, different aspects of functioning need to be investigated. This includes including cognitive, motor, behavioural and emotional skills as well as any clinical disorders such as autistic spectrum disorder or ADHD. ConcePTION researchers gathered 25 experts from 13 countries with diverse professional backgrounds to develop recommendations on how to conduct studies on pregnancy, medicine safety and neurodevelopment. | READ MORE >>
Jun
19
2023
The risks associated with infants being exposed to medicines via breastfeeding is an obvious driver for the need for assessment of medicine safety and lactation. The ConcePTION project is using both clinical and non-clinical methods to study medicine safety. Now, experts from the project publish an expert opinion on medicine safety in breastfeeding focusing on the use of pharmacokinetic modeling. | READ MORE >>
May
15
2023
Women often use medicines while breastfeeding, but we have very little information on how the mother’s medicines affect the breastfed infant. Researchers in the ConcePTION project have developed a generic work flow for predicting medicine concentrations in breast milk using physiologically-based pharmacokinetic (PBPK) modelling, just published in Pharmaceutics. | READ MORE >>
May
08
2023
On 20 April 2023, we organised a webinar on using real word data for research on medication safety during pregnancy and breastfeeding. During the webinar, Miriam Sturkenboom & Marieke Hollestele from University Medical Center Utrecht, the Netherlands, Rosa Gini from Agenzia regionale di sanita della Toscana, Italy and Vjola Hoxhaj from University Medical Center Utrecht, the Netherlands discussed the opportunities and challenges of using real-world data to investigate the safety of medications during pregnancy and breastfeeding. | READ MORE >>
Apr
27
2023
Where can we find data that links infant outcomes, breastfeeding and medicine exposure? A new systematic scoping review from ConcePTION shows that the information that is available is not enough. And calls for action to provide long term population-based data and to monitor infants for adverse effects. | READ MORE >>
Apr
12
2023
Join us on 20 April 2023, 14-15 CEST to discuss the opportunities and challenges of using real-world data to study medicine safety during pregnancy and breastfeeding. In the webinar, you will learn more about how real-world data can inform clinical and regulatory decision-making, and improve the health of both pregnant women and their children! | READ MORE >>
Apr
04
2023
ConcePTION researchers have published a set of recommendations about the core data elements which should be collected when performing studies of medication use in pregnancy. These recommendations include all the key variables that are required in studies assessing both immediate pregnancy/infant outcomes, and longer-term childhood outcomes following maternal medication use in pregnancy. The article, just published in Drug Safety describes the process used to generate the recommendations, and provides the peer-reviewed first version of the recommendations. An online version of the recommendations is also available on the ENTIS website which can be searched and filtered. | READ MORE >>
Mar
02
2023
On 15 February, Coordinator Miriam Sturkenboom & Project Leader Michael Steel presented our efforts to build a safety evidence ecosystem for medicines in pregnancy & breastfeeding. A recording of the webinar is now available, together with slides from the presentation. | READ MORE >>
Feb
14
2023
How can we stimulate reporting of medicine use in pregnancy & breastfeeding? On 15 March, the ConcePTION project is launching a toolkit with a step-by-step guide for developing communications campaigns to stimulate reporting of medicine use during pregnancy and breastfeeding! We provide hands-on guidance for TIS-centres, health authorities and other stakeholders to support them in setting up their local, tailored campaigns. | READ MORE >>
Feb
03
2023
The ConcePTION project is developing a data quality pipeline to evaluate whether observational healthcare data are fit to generate evidence on use and safety of medicines and vaccines. Earlier this year, members of the ConcePTION data pipeline team presented results at the Make Health Data Latam conference on 11-13 January held in Valparaiso, Chile, sharing experiences with researchers and innovators from Latin America regarding the use and interoperability of healthcare records, artificial intelligence, and local solutions to the challenges in the region based on data sciences. | READ MORE >>
Jan
10
2023
The ConcePTION project is designing and building a lasting ecosystem of data collections, methods, people and infrastructures, that allow generation and dissemination of evidence on medicine safety in pregnancy and lactation. Addressing a knowledge gap for mothers and health care professionals, impacting more than 5 million women across the European Union that get pregnant every year. Join us on 15 February at 15:00 CET to learn how the ConcePTION is bridging this gap in an efficient, systematic and ethically responsible way! | READ MORE >>
Dec
07
2022
Postpartum depression is surprisingly common, affecting some 10-15% of new mothers. Antidepressants are often prescribed, which raises questions about how safe it is to breastfeed while undergoing medical treatment. This is of course a concern for parents, who want to know if their baby will suffer any adverse effects. But nurses, midwives, pharmacists and doctors rarely have the evidence needed to help women make an informed choice between breast and bottle. An editorial in the Pharmaceutical journal raises this and other questions that parents often do not ask, but where health care professionals could provide both answers and support to parents. | READ MORE >>
Dec
01
2022
The impact of medicine use in pregnancy is difficult to study. There has been increasing attention to how particular medicines can affect children’s neurodevelopment. The ConcePTION project recently published an inventory of European data sources that can support research on the neurodevelopmental effects of exposure to medicines in pregnancy. | READ MORE >>
Nov
25
2022
Interested in the ethics of research on medications during pregnancy? Marieke Hollestelle will be presenting her talk, “Ethical Considerations When Using Real World Data for Research on Medication Safety in Pregnancy" at an event on 1 December 2022, organised by Harvard Program on Perinatal and Pediatric Pharmacoepidemiology (H4P). Her presentation will be followed by discussion with Drs. Krista Huybrechts, Ameet Sarpatwari, and Sonia Hernandez-Diaz. | READ MORE >>
Nov
07
2022
Today marks the start of #MedSafetyWeek, putting the spotlight on how patients and health care providers can make safety work! One challenge for pregnancy and breastfeeding is the fact that pharmacovigilance data is heterogenous and scattered, making it hard to generate evidence. Another is the fact that the information that is out there about what is safe and what is not is often conflicting. Making it difficult for women and their doctors to make informed decisions about medicines in pregnancy. But just like everyone else, pregnant women sometimes need to take medicines. Sometimes the reason has nothing to do with pregnancy, like headaches, allergies or chronic illness. Sometimes health problems start or get worse when a woman is pregnant, like diabetes, morning sickness or high blood pressure. Sometimes women take medicines before they know that they are pregnant. If women and health-care professionals report medicine use during pregnancy, that information can help women make informed decisions about the benefits and risks of different treatments! | READ MORE >>
Oct
24
2022
With pregnancy being a risk factor, the pandemic put more strain on an already vulnerable group. And without safety data for new vaccines and treatments in pregnancy and breastfeeding, women and their doctors were not able to make informed health choices. This year, the Safe Motherhood Week is targeting this and other inequalities by focusing on upholding maternal rights in a time of crisis. Which is very much in line with the ConcePTION mission to develop an ecosystem for medicine safety in pregnancy and breastfeeding. | READ MORE >>
Sep
20
2022
Recommendations for the adequate doses for medication in pregnancy are often missing. This can lead to suboptimal care. As part of Project MADAM (Model-Adjusted Doses for All Mothers), researchers are using new kinds of evidence to issue dose recommendations for pregnant women. You can also contribute by helping the MADAM project to share their surveys with healthcare practitioners and pregnant women! | READ MORE >>
Aug
26
2022
To be able 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. In case you missed our webinar on the ConcePTION European Breast Milk Collection in May this year, we are now sharing a recording of the presentations! | READ MORE >>
Aug
11
2022
The label on most medicines are missing information on safety in pregnancy and breastfeeding. To address this gap, pharmaceutical companies are requested to develop post-approval studies to assess safety. But even when companies carry out these post approval observational studies to generate evidence of safety data, a landscape study from the ConcePTION project published in Drug Safety, shows that the results rarely make it to the product label. | READ MORE >>
Aug
08
2022
A new paper from Swansea University in collaboration with ConcePTION has called for breastfeeding data to be routinely collected in healthcare databases so that the long-term impacts of medicines taken by women during pregnancy and when breastfeeding, can be better understood. In the paper, which has been published in the International Breastfeeding Journal researchers argue that the lack of data collection on breastfeeding represents a significant ‘blind spot’ leading to an ‘information desert’ in understanding the impact that taking medicines during and after pregnancy, has on breastfeeding rates and long-term infant development. | READ MORE >>
Jun
20
2022
Seasonal allergies, diabetes and post-partum depression affect breastfeeding women worldwide. But there is very little information available about the transfer of drugs to breast milk and infants. Women who are breastfeeding are rarely included in clinical trials, but they still deserve to know if their medicines are safe. ConcePTION researchers recently published a paper in the Journal of Chromatography B that describes two developed and validated methods to determine how much of a drug the mother takes also transfers to her breastmilk, and potentially to her infant. | READ MORE >>
Jun
15
2022
Pregnancy is usually not recommended for women suffering from pulmonary arterial hypertension (PAH), a condition characterised by high blood pressure in the lung arteries, because of the high maternal mortality rate. For this reason, there is little to no information about whether or not the medicines these women use are safe during pregnancy and breastfeeding. A recent ConcePTION case report follows and presents the clinical and pharmacokinetic (PK) data of one breastfeeding mother living with PAH and her infant, who were both exposed to medicines used to treat the condition, bosentan and sildenafil, when the infant was 21 months old. | READ MORE >>
Jun
13
2022
The League of League of European Research Universities LERU have published recommendations for good practice in communicating animal research at universities: Putting emphasis on an open and transparent approach. In response to this call, the IMI ConcePTION project have worked to build the consortium ‘s capacity to communicate about animal data: Building a foundation of knowledge about animal data and animal welfare in the consortium. | READ MORE >>
May
24
2022
Pregnancy should be a time of joy and excitement, although inevitably it is also one of apprehension and concern. Mothers want to be as sure as the can be that they are minimising any risks to their unborn or newly-born child. If they take a medicine - as almost 9 out of 10 do during or after pregnancy – they want to feel reassured they are not posing any undue threat. Now, a new Europe-wide project is asking mothers for their insights in order to help improve knowledge of drug safety. | READ MORE >>
Apr
25
2022
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. On May 24 2022 at 14-15 CEST, the IMI ConcePTION project is organising a webinar together with BBMRI-ERIC - The ConcePTION European Breast Milk Collection: Supporting research on medicine safety in breastfeeding. ConcePTION is developing a research infrastructure to collect, store and analyse samples of breast milk and blood. Don't miss the opportunity to learn more about the design of our demonstration studies, recruitment of breastfeeding mothers, lessons learned, and first results! | READ MORE >>
Apr
20
2022
Because pregnant and breastfeeding women are not usually included in clinical trials of new medications, we don’t know enough about the safety of medicines during pregnancy and breastfeeding. But clinical research is not the only way to generate evidence. Using a so-called learning healthcare system approach, care and research align to accelerate evidence by looking at real-life medication use. A recent publication in BMC Pregnancy and Childbirth explores women’s views on adopting such a system, before and during pregnancy as well as while breastfeeding. Using the ConcePTION evidence generation ecosystem as a starting point. | READ MORE >>
Apr
07
2022
BBMRI-ERIC is supporting the establishment of a European Breast Milk Collection. In a joined effort, a comprehensive Quality Management System (QMS) is built up, to secure and control all operations associated with conducting clinical trials, biobanking activities, and downstream analysis procedures at multiple process levels. On 24 May, we are hosting a webinar together on the European Breast Milk Collection! Registration will be announced soon! | READ MORE >>
Mar
29
2022
On 6 April 2022, Bordeaux PharmacoEpi (BPE), the French eHealth Agency (Agence du Numérique en Santé), the university hospital trust of Paris (Assistance Publique - Hôpitaux de Paris), the EHDEN network (European Health Data Evidence Network) and the Health Data Hub (HDH) invites to their conference ‘Health data interoperability: a European challenge for impactful research project’. The conference will be held in both English and French. | READ MORE >>
Mar
22
2022
On 25 January, we invited women, their partners, health care professionals, researchers and representatives from companies that develop medicines and authorities that approve them to join a workshop. The topic of discussion was improving how we collect information to understand the risks and benefits of medicine use in pregnancy and breastfeeding. | READ MORE >>
Mar
17
2022
The Global Pregnancy CoLab runs a discussion series with the aim to facilitate pregnancy health research. Offering a series of monthly presentations of research aiming to understand adverse pregnancy outcomes worldwide. The second lecture in the series will take place on 24 March, with Scarlett Hopkins, director of Alaska Native Clinical Research at Oregon Health & Science University will talk about Challenges and Opportunities for DOHaD Research in Indigenous Populations. | READ MORE >>
Mar
08
2022
Pregnant and breastfeeding women are rarely part of clinical trials, which means we don’t have enough data to know how safe medicines are. To be able to develop evidence, we need to obtain the information straight from the women who take the medicines! ConcePTION is developing an app that will allow women to report the medicines they use, and also provide pregnancy information: using a simple and straightforward interface. The first version of the app will be launched in the UK in the second half of 2022, in collaboration with the UK Medicines and Healthcare products Regulatory Agency, MHRA. Versions for other European languages and countries will follow! | READ MORE >>
Feb
10
2022
Researchers form Swansea University and SAIL Databank are playing a key role in the ConcePTION project, working together with public and private partners to improve the safety of medicines for mums-to-be and breastfeeding mothers. Want to know more? Find out what Professor Sue Jordan, leading the effort from Swansea University, has to say about creating a trusted information ecosystem that uses anonymised data from multi-national data sources! | READ MORE >>
Dec
16
2021
200 million women get pregnant each year, most of them use at least one medication during pregnancy, but safety data are lacking! The ConcePTION project is developing an ecosystem to generate robust evidence on medicines safety information in pregnancy and breastfeeding. Because of the diversity of data across many sites and countries, the ConcePTION common data model is an important part of this safety evidence ecosystem. It enables consistent research approaches to be applied to a large number of datasets across Europe. Something that is needed to fill the knowledge gap regarding medicine safety in pregnancy and breastfeeding. The common data model, and how to harmonize data to support knowledge generation on the safety of medicines for pregnant and breastfeeding women, is described in a paper recently published in Clinical Pharmacology & Therapeutics. | READ MORE >>
Dec
09
2021
On 25 January 2022, the IMI ConcePTION project is organising an online workshop on improving how we collect information to understand the risks and benefits of medicine use in pregnancy and breastfeeding. We invite women, their partners, health care professionals, researchers and representatives from companies that develop medicines and authorities that approve them to join us. Your input will help us fill some of the knowledge gaps on the safety of medicines in pregnancy and breastfeeding, and help us to understand where there are barriers and problems with the existing systems! | READ MORE >>
Nov
08
2021
This week is Safe Motherhood Week, the annual awareness week on maternal and neonatal health. This year’s theme is the impact of COVID-19 on maternal health and reproductive care, and the need to reduce the information gap on the safety of medication during pregnancy and breastfeeding. Highlighting the importance of maternal health, especially in light of the current pandemic, and aiming to raise awareness of the persistent information gap. | READ MORE >>
Oct
22
2021
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 >>
Oct
06
2021
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 >>
Sep
29
2021
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 >>
Sep
17
2021
Today is world patient safety day, highlighting safe maternal and newborn care. Women who are pregnant sometimes need medicines. Sometimes the reason is a headache, an allergy or a chronic illness. Sometimes health problems start or get worse in pregnancy, like diabetes, morning sickness or high blood pressure. But often there is not enough evidence to give the woman trustworthy information about how her particular medicine might affect the fetus. To bridge the knowledge gap, we are now calling women and their doctors to contribute data by reporting medicine use in pregnancy! | READ MORE >>
Aug
11
2021
Epithelial cells play an important role in the production of breast milk and transfer of different substances from mother to baby through milk. The ConcePTION project has developed a model to produce epithelial cell cultures from pigs that can help us study medicine safety in breastfeeding. This model is described in a recent paper in Animals, and part of an effort to develop knowledge for women who need to decide between medical treatments and breastfeeding. | READ MORE >>
Aug
02
2021
Studies of medicines safety and breastfeeding often involve animals. Now IMI’s CONCEPTION project has a plan that could deliver better results while also using fewer animals. | READ MORE >>
Jul
05
2021
EFEMERIS are looking for a PhD fellow or post-doctoral fellow to join their pharmaco-epidemiology team in the Department of Clinical Pharmacology at the Toulouse School of Medicine, University of Toulouse III. Apply now! | READ MORE >>
Jun
08
2021
Finding information about medicine safety in pregnancy and breastfeeding is challenging. But the problem extends beyond a mere lack of data. A recent ConcePTION publication reveals that the recommendations for how a drug should be taken by pregnant and breastfeeding women vary a lot between different information sources. Even between the most credible sources and in both information intended for patients and health care professionals. The authors also identify a critical need to harmonise information within and between countries. | READ MORE >>
Jun
01
2021
Breastfeeding brings many positive effects on the health and wellbeing of both mother and child. But breastfeeding mothers get sick like the rest of us, which means they also need medicines. We believe that each woman should have the right to make decisions about breastfeeding based on information she can trust. We are providing one step in that direction, developing a model for how medicines transfer to milk! | READ MORE >>
May
25
2021
The French health authority ANSM is launching a study to assess the safety of Covid-19 vaccines in pregnancy. The Covacpreg study is part of the enhanced vaccine surveillance system set up by the ANSM and the regional pharmacovigilance centers (CRPV), who are responsible for monitoring the adverse effects of Covid-19 vaccines. The Covapreg study will follow the course of post-vaccination pregnancies until the birth of the child. With the aim to enrich scientific knowledge on the Covid-19 vaccines in pregnancy. | READ MORE >>
May
18
2021
The CONSIGN project will collect data on the impact of Covid-19 in pregnancy with the aim to guide decision-making about vaccination policies and treatment options for COVID-19 in pregnancy. The project is carried out in collaboration with ConcePTION, the COVI-PREG project, and the International Network of Obstetric Survey Systems (INOSS) network, with an open invitation for more researchers to join! The end goal is to create a sustainable global infrastructure that can be used for prospective monitoring of the benefits and risks of different treatments in pregnancy. Extending well beyond the current Covid-19 health crisis. | READ MORE >>
Apr
26
2021
Developing evidence for medicine safety in pregnancy and breastfeeding is a complex task. To solve the problem, ConcePTION brings together stakeholders and experts from a wide range of disciplines. Each with their own expertise and precise terminology. To align our work and develop a joint understanding of both questions and results, we have developed a glossary that is now available online for anyone to use! | READ MORE >>
Apr
21
2021
ENTIS is a global collaborative network of Teratology Information Services and a key partner in the IMI ConcePTION project. On the 14th April 2021, the ENTIS Board and Scientific Committee announced the official position of the ENTIS organisation to encourage the use of COVID-19 vaccines in pregnant and lactating women, where the benefits are considered to outweigh the risks. | READ MORE >>
Apr
19
2021
Migraine is the third most common disease in the world, and women are three times more likely to suffer from migraines than men. Severe migraine attacks are disabling and require medication. Because many women suffer from migraines, it is important to know how safe migraine medicines are in pregnancy. Adding to the evidence, we have performed a systematic review and meta-analysis summarizing the safety profile of medications used to treat migraines. The study is published in Journal of Neurology and will support women and their doctors when deciding on how to best treat migraines! | READ MORE >>
Apr
13
2021
ConcePTION is building a model that can predict how medicines transfer to breast milk. But because a mother’s milk is made just for her baby, we need to know how and if it is possible to compare humans to other animals. Part of that work is now published in a review where we map the anatomy, physiology and milk composition of the most common laboratory animals. | READ MORE >>
Apr
01
2021
Just like everyone else, pregnant women sometimes need to take medicines. Sometimes the reason has nothing to do with pregnancy, like headaches, allergies or chronic illness. Sometimes health problems start or get worse when a woman is pregnant, like diabetes, morning sickness or high blood pressure. Sometimes women take medicines before they know that they are pregnant. Often there is not enough evidence to give women trustworthy information about how her particular drug might affect the fetus. This is why women and health-care professionals should always report any medicines taken during pregnancy! Your information can help women make informed decisions about the benefits and risks of different treatments! | READ MORE >>
Mar
08
2021
Women who are pregnant and breastfeeding mothers deserve to know if a medicine is safe. The Innovative Medicines Initiative ConcePTION project has a huge and difficult task ahead: Building a system for drug safety in pregnancy and breastfeeding. We bring universities, pharmaceutical companies and the authorities that approve medicines together in partnership: Joining forces to turn data into evidence! | READ MORE >>
Mar
02
2021
To be able to say that it is safe for a pregnant woman to take a particular medicine, we need to know that the safety data is robust. The ConcePTION project is piecing European data together, building a system to generate evidence on medicine safety for pregnant and breastfeeding women. A recent report provides an inventory of the core elements that are needed to generate the evidence that is required. The report guides researchers in performing high quality and meaningful population-based studies: allowing women and their doctors to make informed decisions and weigh the benefits against the risks of treatments. | READ MORE >>
Feb
03
2021
The ConcePTION project is committed to building safety evidence for women and their doctors. One of our first contributions is a systematic review and meta-analysis of pregnancy and fetal outcomes in women with Multiple sclerosis (also known as MS). The results add to the existing evidence for women with MS considering pregnancy and for neurologists deciding on treatment during pregnancy and counselling women with unplanned pregnancies. The meta-analysis also highlights the need for more studies to address the lack of evidence. The authors are currently performing further studies within IMI ConcePTION to address some of these knowledge gaps. | READ MORE >>
Feb
01
2021
Breastfeeding offers health and wellbeing benefits for both mother and child. Half of new mothers need medicines. Many medicines are likely to be safe, but human lactation studies are challenging to conduct. As a result, women often have to choose between continuing their medical treatment and breastfeeding their infant. In a recent Biomedicine & Pharmacotherapy publication, ConcePTION researchers provide an extensive overview of non-clinical and computational methods that can be used to inform human lactation studies. And how these methods can be combined to enable prediction of medicine transfer into breast milk when human lactation studies cannot be performed. | READ MORE >>
Jan
25
2021
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 breastfeeing, 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. We have developed ten principles to ensure we conduct our engagement activities in an ethical way. | READ MORE >>
Jan
20
2021
The information that is available to women and healthcare professionals about medicine use in pregnancy and breastfeeding is often both inconsistent and inadequate. Recently, the UK Safer Medicines in Pregnancy and Breastfeeding Information Consortium published an information strategy. The vision of this strategy is for all women to have access to accurate and accessible information, allowing them to make informed decisions about medicines together with health care professionals. | READ MORE >>
Dec
21
2020
2020 was a challenging year for all of us, having an impact on our work and private lives alike. Despite adapting to a global pandemic, we have made amazing progress in our project and achieved many milestones on our way to improve the information for pregnant and breastfeeding women worldwide. With 88 partners from 22 countries, we should be proud of being part of a unique project that is set out to improve the situation in an orphan and neglected topic! | READ MORE >>
Dec
16
2020
Pregnant women make decisions about medicines based on insufficient, incomplete and randomly available information with varying quality. More than five million European women become pregnant every year. Most of them use at least one medicine during their pregnancy. A recent master thesis from the ConcePTION project shows that giving women easy access to information from sources they can trust can empower them to make decisions about medicines in pregnancy. | READ MORE >>
Nov
04
2020
Many women need medication during pregnancy and breastfeeding in order to treat health conditions. However, they often choose to stop their medication. I meet these women in my clinical practice. Many of them have underlying medical problems, anything from common ailments (such as headaches or heartburn) to autoimmune diseases, to heart and kidney disease or even an organ transplant. Naturally, they worry about the medicines they are taking for fear that they might harm their baby. Ken Hodson, Head of the UK Teratology Information Service (www.uktis.org) and consultant obstetrician with a specialist interest in medical problems in pregnancy in Newcastle upon Tyne, UK shares his thoughts on this year's #MedSafetyWeek! | READ MORE >>
Nov
02
2020
This week, the Innovative Medicines Initiative project, ConcePTION, is part of the fifth annual social media campaign called #MedSafetyWeek. The purpose is to raise awareness about the importance of reporting suspected side effects from medicines to national health authorities, registries and drug manufacturers. This year, ConcePTION is adding an important message to this campaign. We are calling on women and health care professionals to report any medications used during pregnancy and breastfeeding. This is important, even if you do not think you are experiencing any side effects. Why? Because information about medicine safety for pregnant and breastfeeding women is desperately lacking. Every report counts, and adds knowledge about how safe medicines are for both mums and babies! | READ MORE >>
Oct
20
2020
Like many others, the ConcePTION project had to cancel all face-to-face events this year and move online. This week we discuss our progress at the ConcePTION virtual general assembly. We look forward to two full days of progress reporting and constructive discussion. We are beginning to answer the question of how we can move beyond pregnancy registries to better understand disease-related pregnancy outcomes, medication use medicine safety in pregnancy. We also celebrate steps in the establishment of a non-commercial, Europe-wide breast milk biobank and platform to analyse samples. And a lot more! Want to know more? Join us at #ConcePTIONvirtual2020 on Twitter on 21-22 October! | READ MORE >>
Oct
14
2020
This year, ConcePTION is part of the annual online event organised by the Motherhood Collective Impact Programme (MCIP). Here, Helena Harnik, MCIP programmes director from the Synergist, explains how ConcePTION plays a role in addressing some of the most challenging issues in maternal health: building knowledge about how safe women’s medicines are in pregnancy and nursing. And why this knowledge matters. | READ MORE >>
May
04
2020
This week is Maternal Mental Health Awareness week, highlighting an important issue for all pregnant women and new mothers. Worldwide at least 1 in every 10 pregnant women experience a mental health disorder, including depression and anxiety. Many of these women will need treatment with medicines. | READ MORE >>
Mar
16
2020
On 13 March 2020, the WHO issued the second edition of their interim guidance for clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. | READ MORE >>
Feb
03
2020
The Lausanne University Hospital (CHUV) is one of five Swiss university hospitals. Through its collaboration with the Faculty of Biology and Medicine of the University of Lausanne and the EPFL, CHUV plays a leading role in the areas of medical care, medical research and training. The drug in real life unit is part of the new Centre de Recherche et Innovation en Sciences Pharmaceutiques Cliniques – CRISP. Its research activities focus on how drugs are used once they are on the market and how their use can be improved. | READ MORE >>
Nov
12
2019
The Motherhood Collective Impact program (MCIP) is a not-for-profit partnership that aims to address the most challenging issues in maternal health by taking a new, co-impact and systems-based approach. From 14th - 20th October 2019 they held their annual Safe Motherhood week. The theme of this year was: Accessibility to quality maternal care and safe medication. MCIP spoke with our project leads (Dr. Ida Niklson, (Novartis) & Prof. Dr. Miriam Sturkenboom (UMC Utrecht)) on how ConcePTION will bridge the knowledge gap for pregnant and breastfeeding women. | READ MORE >>
Oct
31
2019
Uppsala Monitoring Centre is the WHO collaborating Centre for International Drug Monitoring with members in more than a network 150 countries. Which profides a global network for pharmacovigilance. In the recent issue of their magazine Reports they focus on the needed search for drug safety facts for pregnant and breastfeeding women with a lengthy interview of two partners of ConcePTION. | READ MORE >>
Oct
17
2019
Several consortium partners currently have job opportunities related to the ConcePTION project. Would you like to contribute to our important mission? Please have a look at the current vacancies below. | READ MORE >>
Oct
14
2019
On September, IMI ConcePTION has successfully launched the first of two surveys to collect information on women’s needs and preferences on information about the medicines or drugs used during pregnancy and breastfeeding. | READ MORE >>
May
05
2019
ConcePTION: ‘Building a pan-European ecosystem for generating, monitoring, and providing robust information on medication safety in pregnancy and breastfeeding’ | READ MORE >>
Apr
01
2019
On 1-April 2019 the IMI project ConcePTION officially started. The project will tackle many of the research gaps related to medicine used by pregnant and breastfeeding women. | READ MORE >>
