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 >>