ConcePTION

Building an ecosystem for better monitoring and communicating of medication safety in pregnancy

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:
Newcastle University (United Kingdom)
Ucb Biopharma Sprl (Belgium)
Sanofi-Aventis Recherche & Developpement (France)
Università  degli Studi di Ferrara - Amministrazione Centrale (Italy)
Elevate Bv (Netherlands)
Orcion Bv (Netherlands)
Uppsala Universitet (Sweden)
The University Of Manchester (United Kingdom)
European Forum For Good Clinical Practice (Belgium)
Teva Pharmaceutical Industries Limited (Israel)
NOVO NORDISK S.p.A. (Italy)
European Educational Programme in Epidemiology c/o Agenzia Regionale Sanità Toscana (Italy)
Karolinska Institutet (Sweden)
Stockholms Laens Landsting (Sweden)
Medicines And Healthcare Products Regulatory Agency (United Kingdom)
Pfizer Limited (United Kingdom)
Rijksinstituut Voor Volksgezondheid En Milieu-National Institute For Public Health And The Environment (Netherlands)
University Of Kwazulu-Natal (South Africa)
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica En La Comunitat Valenciana (Spain)
Takeda Development Centre Europe Ltd (United Kingdom)
The European Medicines Agency (United Kingdom)
Centre Hospitalier Universitaire De Toulouse (France)
European Institute Of Women'S Health Limited (Ireland)
Eli Lilly & Company Limited (United Kingdom)
Janssen Pharmaceutica Nv (Belgium)
Inserm (France)
Novartis Pharma Ag (Switzerland)
Bionotus (Belgium)
Consiglio Nazionale Delle Ricerche (Italy)
Academisch Ziekenhuis Groningen (Netherlands)
Stichting Lareb (Netherlands)
Universitetet I Oslo (Norway)
Universite' De Geneve (Switzerland)
Swansea University (United Kingdom)
Ellegaard Gottingen Minipigs A/S (Denmark)
ALMA MATER STUDIORUM - Università di Bologna (Italy)
Ttopstart Bv (Netherlands)
Stichting Entis (European Network Teratology Information Services) Foundation (Netherlands)
Covance Laboratories Ltd (United Kingdom)
Bristol-Myers Squibb Company (United States of America)
AbbVie Inc. (United States of America)
Biobanks And Biomolecular Resources Research Infrastructure Consortium (Bbmri-Eric) (Austria)
The European Institute For Innovation Through Health Data (Belgium)
THL - TERVEYDEN JA HYVINVOINNIN LAITOS - Department of Welfare - National Institute for Health and Welfare (Finland)
Merck KGaA (Germany)
University Of Ulster (United Kingdom)
Glaxosmithkline Research And Development Ltd. (United Kingdom)
St Georges Hospital NHS Trust (United Kingdom)
Katholieke Universiteit Leuven (Belgium)
The Synergist (Belgium)

Total Eu Contribution: Euro (EUR) 15.299.991,00
Project Duration in months: 60
Start Date: 01/04/2019
End Date: 31/03/2024

Cordis webpage
Project website

Good health and well-being This project contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.

UE flag This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 821520