Abstract
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, (4) 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.
Project details
Unibo Team Leader: Monica Forni
Unibo involved Department/s:
Dipartimento di Scienze Mediche Veterinarie
Coordinator:
Universitair Medisch Centrum Utrecht (Umcu)(Netherlands)
Other Participants:
The European Medicines Agency
(United Kingdom)
The University Of Manchester
(United Kingdom)
Biobanks And Biomolecular Resources Research Infrastructure Consortium (Bbmri-Eric)
(Austria)
ALMA MATER STUDIORUM - Università di Bologna
(Italy)
Universite' De Geneve
(Switzerland)
Katholieke Universiteit Leuven
(Belgium)
Orcion Bv
(Netherlands)
Karolinska Institutet
(Sweden)
Newcastle University
(United Kingdom)
AbbVie Inc.
(United States of America)
Ellegaard Gottingen Minipigs A/S
(Denmark)
THL - TERVEYDEN JA HYVINVOINNIN LAITOS - Department of Welfare - National Institute for Health and Welfare
(Finland)
Merck KGaA
(Germany)
Università degli Studi di Ferrara - Amministrazione Centrale
(Italy)
Stichting Entis (European Network Teratology Information Services) Foundation
(Netherlands)
Universitetet I Oslo
(Norway)
Eli Lilly & Company Limited
(United Kingdom)
Pfizer Limited
(United Kingdom)
Janssen Pharmaceutica Nv
(Belgium)
The Synergist
(Belgium)
Inserm
(France)
Sanofi-Aventis Recherche & Developpement
(France)
Teva Pharmaceutical Industries Limited
(Israel)
Academisch Ziekenhuis Groningen
(Netherlands)
Elevate Bv
(Netherlands)
Stockholms Laens Landsting
(Sweden)
Novartis Pharma Ag
(Switzerland)
Medicines And Healthcare Products Regulatory Agency
(United Kingdom)
Glaxosmithkline Research And Development Ltd.
(United Kingdom)
Covance Laboratories Ltd
(United Kingdom)
Bristol-Myers Squibb Company
(United States of America)
European Forum For Good Clinical Practice
(Belgium)
European Institute Of Women'S Health Limited
(Ireland)
NOVO NORDISK S.p.A.
(Italy)
Stichting Lareb
(Netherlands)
UPPSALA UNIVERSITET - Uppsala Genome Center
(Sweden)
University Of Ulster
(United Kingdom)
St Georges Hospital NHS Trust
(United Kingdom)
Swansea University
(United Kingdom)
Ucb Biopharma Sprl
(Belgium)
Centre Hospitalier Universitaire De Toulouse
(France)
European Educational Programme in Epidemiology c/o Agenzia Regionale Sanità Toscana
(Italy)
Consiglio Nazionale Delle Ricerche
(Italy)
Rijksinstituut Voor Volksgezondheid En Milieu-National Institute For Public Health And The Environment
(Netherlands)
Ttopstart Bv
(Netherlands)
Takeda Development Centre Europe Ltd
(United Kingdom)
Bionotus
(Belgium)
University Of Kwazulu-Natal
(South Africa)
The European Institute For Innovation Through Health Data
(Belgium)
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica En La Comunitat Valenciana
(Spain)
Total Eu Contribution: Euro (EUR) 15.299.991,00
Project Duration in months: 69
Start Date:
01/04/2019
End Date:
31/12/2024
Cordis webpage
Project website
This project contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 821520