Building an ecosystem for better monitoring and communicating of medication safety in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation


Women who are pregnant or breastfeeding are traditionally excluded from medical research due to safety concerns. As a result of this, only 5 % of medications have adequate safety information on their use in pregnant or breastfeeding women, and this makes it very hard for doctors and women to make informed decisions about their treatment. Nonetheless, some 90 % of women are exposed to a prescription medication at some point during their pregnancy.

The ultimate goal of ConcePTION is to create a trusted biomedical ecosystem capable of providing evidence-based information on the safety of medications during pregnancy and breastfeeding in an efficient, systematic and ethically responsible way. The information will be provided in a form that is usable by both healthcare providers and patients alike.

The project will achieve this in a number of ways. Firstly, it will improve and unify existing approaches to data collection in this area by re-using existing, de-identified data generated during routine patient care. The project also aims to deliver procedures and tools for the collection of digital data and samples directly from pregnant women.

They will also create the first Europe-wide breast milk biobank for research purposes, and develop tools to predict which drugs are likely to be transferred to breast milk. Finally, the team will establish a web-based drug information knowledge bank.

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A new way of studying an old question – which medicines can be taken safely while breastfeeding?

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.###

One of the aims of the CONCEPTION project is to deliver knowledge, tools and resources so that breastfeeding women and their doctors can take an informed decision about whether or not it is safe to breastfeed while taking a given medication. As part of this effort, the project is collecting samples of milk from breastfeeding women. However, on its own, this is not enough, and so the project is investigating other ways of studying which medicines are likely to make it into breast milk.

Currently, three types of models are used to help answer this question. In vitro models consist of cells in a dish or test tube, while in silico models are computer based. CONCEPTION is working to improve in vitro and in silico models. Finally, there are animal (in vivo) models, which are useful for analysing the mechanics of how a medicine makes it into the breast milk. CONCEPTION researchers recently published an extensive review of the pros and cons of different animals as models for research on breastfeeding.

Ultimately, the CONCEPTION team believes that the best way of studying which medicines get into breast milk is to combine in vivoin vitro and in silico models.

How would combining approaches work in practice? ‘The approaches used are directly connected through a continuous flow of information,’ explains Alberto Elmi of the University of Bologna. ‘Moreover, both in vitro and in vivo data feed the mathematical approaches of the in silico platform, and this will further strengthen the other models. In addition, use of the human lactation data collected elsewhere in the project will allow us to validate the in silicoin vivo and in vitro platforms.’ 

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IMI’s EHDEN and ConcePTION projects to work with EMA on COVID-19

The EHDEN and ConcePTION projects plus the ADVANCE/VAC4EU initiative will help the European Medicines Agency (EMA) gather real world data on COVID-19 vaccines and treatments once they are approved and being used in day-to-day clinical practice.###

EHDEN is already working with 25 data partners across Europe, to help them map COVID-19 data to a common data model. Now, it is set to collaborate with the EMA on the creation of a framework for multicentre cohort studies on the use of medicines in COVID-19 patients.

ConcePTION will collaborate with the EMA on a project that will collect data on the impact of COVID-19 in pregnancy and follow up the baby to monitor long-term outcomes in order to guide decision-making about vaccine indications, vaccination policies and treatment options for COVID-19 in pregnant women.

The international association VAC4EU (Vaccine Monitoring Collaboration for Europe) is set to work with the EMA to prepare for the monitoring of the benefits and risks of COVID-19 vaccines in Europe. VAC4EU was born out of IMI’s ADVANCE project.

‘The inclusion of EHDEN, ConcePTION and VAC4EU in the EMA’s work is testament not only to their scientific excellence but to their ability to adapt to the challenges posed by the COVID-19 pandemic,’ said IMI Executive Director Pierre Meulien. ‘I am confident that the projects will make a valuable contribution to this important initiative which is a key part of the global fight against the disease.’

The outcomes of the projects will feed into the work of EMA’s COVID-19 EMA pandemic Task Force (COVID-ETF) and EMA’s scientific committees, to ensure that the evidence is translated into scientific opinions on the optimal use of the medicines and vaccines concerned.

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Contribute to the survey on medication safety for new and expectant mothers

Evidence suggests that up to 95 % of the five million women who get pregnant in the EU every year will reach for a prescription drug at some point. And yet, only about 5 % of the medication they take comes with pregnancy and breast-feeding-related safety information. Now, IMI’s ConcePTION project is working to fill the data gap. ###As a first step, they are running a survey to gather as much information as possible about how women who are pregnant or breastfeeding are currently making choices about medication.

Elsewhere, the project aims to establish new and better ways to collect digital data and samples; create a Europe-wide breast milk biobank for research; develop tools to predict transferability of drugs medicines into breastmilk; and build a web-based drug info bank, presented in a way that women have a reliable single source and don’t need a medical degree to understand.


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EFPIA companies
  • Abbvie Inc, North Chicago, Illinois, United States
  • Bristol-Myers Squibb Company Corp, Princeton, NJ, United States
  • Eli Lilly And Company LTD, Basingstoke, United Kingdom
  • Ellegaard Gottingen Minipigs As, Dalmose, Denmark
  • Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Labcorp Early Development Laboratories Limited, Harrogate, United Kingdom
  • Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
  • Novartis Pharma AG, Basel, Switzerland
  • Novo Nordisk A/S, Bagsvaerd, Denmark
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
  • Takeda Pharmaceuticals International AG, Glattpark-Opfikon (Zurich), Switzerland
  • Teva Pharmaceutical Industries Limited, Netanya, Israel
  • UCB Biopharma, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Academisch Ziekenhuis Groningen, Groningen, Netherlands
  • Agenzia Regionale Di Sanita, Firenze, Italy
  • Alma Mater Studiorum - Universita Di Bologna, Bologna, Italy
  • Biobanks And Biomolecular Resources Research Infrastructure Consortium (Bbmri-Eric), Graz, Austria
  • Centre Hospitalier Universitaire De Toulouse, Toulouse Cedex 09, France
  • Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
  • Consiglio Nazionale Delle Ricerche, Roma, Italy
  • European Forum For Good Clinical Practice, Brussels, Belgium
  • European Institute Of Women'S Health Company Limited By Guarantee, Dublin, Ireland
  • Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana, Valencia, Spain
  • Institut National De La Sante Et De La Recherche Medicale, Paris, France
  • Karolinska Institutet, Stockholm, Sweden
  • Katholieke Universiteit Leuven, Leuven, Belgium
  • Medicines And Healthcare Products Regulatory Agency, London, United Kingdom
  • Region Stockholm, Stockholm, Sweden
  • Region Uppsala, Uppsala, Sweden
  • Rijksinstituut Voor Volksgezondheid En Milieu, Bilthoven, Netherlands
  • St George'S Hospital Medical School, London, United Kingdom
  • Stichting Entis (European Network Teratology Information Services) Foundation, Hertogenbosch, Netherlands
  • Stichting Lareb, 's Hertogenbosch, Netherlands
  • Swansea University, Swansea, United Kingdom
  • Terveyden Ja Hyvinvoinnin Laitos, Helsinki, Finland
  • The European Institute For Innovation Through Health Data, Gent, Belgium
  • The European Medicines Agency, Canary Wharf, London, United Kingdom
  • The Newcastle Upon Tyne Hospitals Nhs Foundation Trust, Newcastle-Upon-Tyne, United Kingdom
  • The University Of Manchester, Manchester, United Kingdom
  • Universita Degli Studi Di Ferrara, Ferrara, Italy
  • Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
  • Universitetet I Oslo, Oslo, Norway
  • University Of Kwazulu-Natal, Westville, South Africa
  • University Of Ulster, Coleraine, United Kingdom
  • Uppsala Universitet, Uppsala, Sweden
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Bionotus, Temse, Belgium
  • Elevate BV, Utrecht, Netherlands
  • Orcion BV, Asten, Netherlands
  • The Synergist, Bruxelles, Belgium
  • Ttopstart BV, Bilthoven, Netherlands
Third parties
  • Hospices Civils De Lyon, lyon, France
  • Manchester University Nhs Foundation Trust, Manchester, United Kingdom
  • Masarykova univerzita, Brno, Czech Republic
  • Medizinische Universitat Graz, Graz, Austria
  • Ministry Of Health, Jerusalem, Israel
  • Nearshore Macedonia LTD Skopje, Skopje, North Macedonia
  • Shamir Health Corporation, Zrifin, Israel
  • Srebrnjak Children's Hospital, Zagreb, Croatia
  • Synergist Services, Bruxelles, Belgium
  • Universitaet Leipzig, Leipzig, Germany

NameEU funding in €
Academisch Ziekenhuis Groningen260 939
Agenzia Regionale Di Sanita359 110
Alma Mater Studiorum - Universita Di Bologna832 760
Biobanks And Biomolecular Resources Research Infrastructure Consortium (Bbmri-Eric)201 000
Bionotus355 144
Centre Hospitalier Universitaire De Toulouse912 929
Centre Hospitalier Universitaire Vaudois482 806
Consiglio Nazionale Delle Ricerche143 223
Elevate BV110 919
European Forum For Good Clinical Practice94 993
European Institute Of Women'S Health Company Limited By Guarantee135 160
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana89 869
Institut National De La Sante Et De La Recherche Medicale60 721
Karolinska Institutet68 208
Katholieke Universiteit Leuven1 052 746
Medicines And Healthcare Products Regulatory Agency108 219
Orcion BV94 126
Region Stockholm119 911
Region Uppsala171 140
Rijksinstituut Voor Volksgezondheid En Milieu107 321
St George'S Hospital Medical School370 324
Stichting Entis (European Network Teratology Information Services) Foundation303 262
Stichting Lareb848 023
Swansea University171 183
Terveyden Ja Hyvinvoinnin Laitos308 039
The European Institute For Innovation Through Health Data466 011
The European Medicines Agency85 000
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust552 695
The Synergist137 421
The University Of Manchester355 466
Ttopstart BV67 130
Universita Degli Studi Di Ferrara275 674
Universitair Medisch Centrum Utrecht2 486 436
Universitetet I Oslo806 665
University Of Kwazulu-Natal132 722
University Of Ulster692 410
Uppsala Universitet894 281
Third parties
NameFunding in €
Hospices Civils De Lyon39 334
Manchester University Nhs Foundation Trust8 784
Masarykova univerzita42 420
Medizinische Universitat Graz60 000
Ministry Of Health26 250
Nearshore Macedonia LTD Skopje141 188
Shamir Health Corporation70 000
Srebrnjak Children's Hospital5 720
Synergist Services167 312
Universitaet Leipzig25 000
Total Cost15 299 994