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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

Objective

ConcePTION partners have united around a shared vision that we have a societal obligation to radically and rapidly reduce uncertainty about the safety of medication use in pregnancy and lactation.

What do we deliver? ConcePTION aims to create a paradigm shift in how we study medication safety in pregnancy. We will establish (1) a successful, sustainable open-science based EU non-proprietary ecosystem of public and private stakeholders, pregnant women and researchers to generate and disseminate timely and reliable evidence on drugs across maternal, neonatal and long term outcomes of medication exposure in pregnancy and breastfeeding (2) a catalogue with fully characterized data sources for rapid selection of suitable data sources; 3) operational, business, network, information and data governance models, (4) quality assured and tested methodological approaches, analytical tools and data platforms allowing for distributed analyses, (5) procedures and tools for collection of digital data and samples directly from pregnant women, (6) In vitro, in silico and in vivo models for prediction of drug transfer in human milk, (7) a biobank and analytical network for quantification of drug in human milk, (8) best practice documents endorsed by regulators and health authorities and (9) a web-based drug information knowledge bank.

How do we deliver? (1) Experienced leaders, able to manage challenging networks and public-public or public-private partnerships. (2) Defragmentation by connecting all key stakeholders and EU networks in this area. (3) Re-use of data, tools and foreground from prior European commission funded projects. (4) Connecting to leaders of similar initiatives in the USA, Canada, Asia and other parts of the world. (5) Systematic consensus & endorsement building. (6) Quality throughout as a precondition to trust the results and information by all users.

Field of science

  • /natural sciences/biological sciences/ecology/ecosystems
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug
  • /medical and health sciences/clinical medicine/obstetrics and gynaecology/obstetrics

Call for proposal

H2020-JTI-IMI2-2017-13-two-stage
See other projects for this call

Funding Scheme

IMI2-RIA - Research and Innovation action
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Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 2 772 332,50

Participants (52)

UNIVERSITY OF ULSTER
United Kingdom
EU contribution
€ 1 232 181,25
Address
Cromore Road
BT52 1SA Coleraine
Activity type
Higher or Secondary Education Establishments
UPPSALA UNIVERSITET
Sweden
EU contribution
€ 980 421,25
Address
Von Kraemers Alle 4
751 05 Uppsala
Activity type
Higher or Secondary Education Establishments
BIOBANKS AND BIOMOLECULAR RESOURCES RESEARCH INFRASTRUCTURE CONSORTIUM (BBMRI-ERIC)
Austria
EU contribution
€ 328 420
Address
Neue Stiftingtalstrasse 2/B/6
8010 Graz
Activity type
Research Organisations
ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA
Italy
EU contribution
€ 832 760
Address
Via Zamboni 33
40126 Bologna
Activity type
Higher or Secondary Education Establishments
THE EUROPEAN INSTITUTE FOR INNOVATION THROUGH HEALTH DATA
Belgium
EU contribution
€ 466 011,25
Address
Oude Mechelsestraat 165
1853 Strombeek-bever
Activity type
Research Organisations
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 1 052 746,25
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
United Kingdom
EU contribution
€ 108 218,75
Address
10 South Colonnade, Canary Wharf
E14 4PU London
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
STICHTING LAREB
Netherlands
EU contribution
€ 854 410
Address
Goudsbloemvallei 7
5237 MH S Hertogenbosch
Activity type
Research Organisations
AGENZIA REGIONALE DI SANITA
Italy
EU contribution
€ 359 110
Address
Via Pietro Dazzi 1
50141 Firenze
Activity type
Other
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 68 207,50
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 456 193,75
Address
Freeman Hospital, High Heaton
NE7 7DN Newcastle-upon-tyne
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
UNIVERSITY OF KWAZULU-NATAL
South Africa
EU contribution
€ 229 223,75
Address
University Road, Chiltern Hills
3630 Westville
Activity type
Higher or Secondary Education Establishments
UNIVERSITETET I OSLO
Norway
EU contribution
€ 727 915
Address
Problemveien 5-7
0313 Oslo
Activity type
Higher or Secondary Education Establishments
ST GEORGE'S HOSPITAL MEDICAL SCHOOL
United Kingdom
EU contribution
€ 400 423,75
Address
Cranmer Terrace
SW17 0RE London
Activity type
Higher or Secondary Education Establishments
EUROPEAN INSTITUTE OF WOMEN'S HEALTH COMPANY LIMITED BY GUARANTEE
Ireland
EU contribution
€ 135 160
Address
Pearse Street 33
2 Dublin
Activity type
Research Organisations
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 260 938,75
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
ORCION BV
Netherlands
EU contribution
€ 235 313,75
Address
Schutter 11
5721 HW Asten
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 60 721,25
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
BIONOTUS
Belgium
EU contribution
€ 355 143,75
Address
Dorpstraat 61A
9140 Temse
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE
France
EU contribution
€ 652 703,75
Address
Rue Viguerie 2 Hotel Dieu Saint Jacques
31052 Toulouse Cedex 3
Activity type
Higher or Secondary Education Establishments
UNIVERSITA DEGLI STUDI DI FERRARA
Italy
EU contribution
€ 83 586,25
Address
Via Ariosto 35
44121 Ferrara
Activity type
Higher or Secondary Education Establishments
SWANSEA UNIVERSITY
United Kingdom
EU contribution
€ 119 036,25
Address
Singleton Park
SA2 8PP Swansea
Activity type
Higher or Secondary Education Establishments
UNIVERSITE DE GENEVE

Participation ended

Switzerland
EU contribution
€ 0
Address
Rue Du General Dufour 24
1211 Geneve
Activity type
Higher or Secondary Education Establishments
EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE
Belgium
EU contribution
€ 94 992,50
Address
Rue De Washington 40
1050 Brussels
Activity type
Other
THE SYNERGIST
Belgium
EU contribution
€ 286 336,75
Address
Avenue Louise 523
1050 Bruxelles
Activity type
Other
STICHTING ENTIS (EUROPEAN NETWORK TERATOLOGY INFORMATION SERVICES) FOUNDATION
Netherlands
EU contribution
€ 568 816
Address
Goudsbloemvallei 7
5237MH Hertogenbosch
Activity type
Other
THE UNIVERSITY OF MANCHESTER
United Kingdom
EU contribution
€ 338 000
Address
Oxford Road
M13 9PL Manchester
Activity type
Higher or Secondary Education Establishments
REGION STOCKHOLM
Sweden
EU contribution
€ 119 911,25
Address
Hantverkargatan 45
104 22 Stockholm
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
ELEVATE BV
Netherlands
EU contribution
€ 110 918,75
Address
Newtonlaan 203
3584 BH Utrecht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TERVEYDEN JA HYVINVOINNIN LAITOS
Finland
EU contribution
€ 207 038,75
Address
Mannerheimintie 166
00271 Helsinki
Activity type
Research Organisations
CONSIGLIO NAZIONALE DELLE RICERCHE
Italy
EU contribution
€ 70 722,50
Address
Piazzale Aldo Moro 7
00185 Roma
Activity type
Research Organisations
FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA
Spain
EU contribution
€ 79 868,75
Address
Calle Micer Masco 31
46010 Valencia
Activity type
Research Organisations
TTOPSTART BV
Netherlands
EU contribution
€ 67 130
Address
Euclideslaan 1
3584 BL Utrecht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
EU contribution
€ 107 321,25
Address
Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven
Activity type
Research Organisations
THE EUROPEAN MEDICINES AGENCY
Netherlands
EU contribution
€ 85 000
Address
Domenico Scarlattilaan 6
1083 HS Amsterdam
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
JANSSEN PHARMACEUTICA NV
Belgium
EU contribution
€ 0
Address
Turnhoutseweg 30
2340 Beerse
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
NOVARTIS PHARMA AG
Switzerland
EU contribution
€ 0
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
France
EU contribution
€ 0
Address
Pierre Brossolette 1
91380 Chilly Mazarin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TAKEDA DEVELOPMENT CENTRE EUROPE LTD

Participation ended

United Kingdom
EU contribution
€ 0
Address
Aldwych 61
WC2B 4AE London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
EU contribution
€ 0
Address
Great West Road 980
TW89GS Brentford
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Eli Lilly and Company Limited
United Kingdom
EU contribution
€ 0
Address
Lilly House, Priestley Road
RG24 9NL Basingstoke
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
PFIZER LIMITED
United Kingdom
EU contribution
€ 0
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BRISTOL-MYERS SQUIBB COMPANY CORP
United States
EU contribution
€ 0
Address
Park Avenue 345
10154 New York
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN
Germany
EU contribution
€ 0
Address
Frankfurter Strasse 250
64293 Darmstadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
NOVO NORDISK A/S
Denmark
EU contribution
€ 0
Address
Novo Alle 1
2880 Bagsvaerd
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UCB BIOPHARMA SRL
Belgium
EU contribution
€ 0
Address
Allee De La Recherche 60
1070 Bruxelles
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ABBVIE INC
United States
EU contribution
€ 0
Address
North Waukegan Road 1
60064 North Chicago Il
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ELLEGAARD GOTTINGEN MINIPIGS AS
Denmark
EU contribution
€ 0
Address
Soro Landevej 302 Hove
4261 Dalmose
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
COVANCE LABORATORIES LTD
United Kingdom
EU contribution
€ 0
Address
Otley Road
HG3 IPY Harrogate
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Israel
EU contribution
€ 0
Address
5 Basel St
49131 Petach Tivka
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS
Switzerland
EU contribution
€ 392 755,75
Address
Rue Du Bugnon 21
1011 Lausanne
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
TAKEDA PHARMACEUTICALS INTERNATIONAL AG
Switzerland
EU contribution
€ 0
Address
Thurgauerstrasse 130
8152 Glattpark
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)