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ConcePTION

Continuum of Evidence from Pregnancy Exposures, Reproductive Toxicology and Breastfeeding to Improve Outcomes Now

 

Project details:

Call: H2020-JTI-IMI2-2017-13

Start date: 01/03/2019 - end date: 29/02/2024

Total cost: 28.799.991,00 €

EU contribution: 15.299.991,00 €

EU contribution to UniFe: 83.586,25 €

 

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.

 

Participants:

  • Universitair Medisch Centrum Utrecht (UMCU; cordinator), The Netherlands;
  • University of Ulster (ULST), United Kingdom;
  • Uppsala Universitet (UPPS), Sweden;
  • Biobanks and Biomolecular Resourcesresearch Infrastructure Consortium (BBMRI-ERIC), Austria;
  • Alma Mater Studiorum - Università di Bologna (UNIBO), Italy;
  • The European Institute for Innovation through Health Data (iHD), Belgium;
  • Katholieke Universiteit Leuven (KUL), Belgium;
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom;
  • Stichting Lareb (LAREB), The Netherlands;
  • Agenzia Regional di Sanita Tuscany (ARS), Italy;
  • Karolinska Institutet (KI), Sweden;
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust (NUTH), United Kingdom;
  • University of KwaZulu-Natal (UKZN), South Africa;
  • Universitetet I Oslo (UOSL), Norway;
  • St George’s Hospital Medical School (SGUL), United Kingdom;
  • European Institute for Women’s Health, CLG (EIWH), Ireland;
  • Academisch Ziekenhuis Groningen (UMCG), The Netherlands;
  • Orcion BV (ORC), The Netherlands;
  • Institut National de la Santé Et de la Recherche Médicale (INSERM), France;
  • BioNotus (BioNotus), Belgium;
  • Centre Hospitalier Universitaire de Toulouse (CHUT), France;
  • Università degli Studi di Ferrara (FERR), Italy;
  • Swansea University (USWAN), United Kingdom;
  • Universite de Geneve (UNIGE), Switzerland;
  • European Forum for Good Clinical Practice (EFGCP), Belgium;
  • The Synergist (Synergist), Belgium;
  • Stichting ENTIS (European Network Teratology Information Services) Foundation (ENTIS), The Netherlands;
  • The University of Manchester (UMAN), United Kingdom;
  • Stockholms Lans Landsting (SCC), Sweden;
  • Elevate BV (Elevate), The Netherlands;
  • Terveyden Ja Hyvinvoinnin Laitos – National Institute for Health and Welfare (NIHW), Finland;
  • Consiglio Nazionale Delle Richerche – CNR Institute of Clinical Physiology (CNR-IFC), Italy;
  • Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana (FISABIO), Spain;
  • ttopstart (TTOP), The Netherlands;
  • The State of the Netherlands, represented by the Minister of Health, Welfare and Sport, on behalf of the Minister represented by Mr.Prof.dr.ir.J. Brug, Director-General of the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu (RIVM)), The Netherlands;
  • The European Medicines Agency (EMA), The Netherlands;
  • Janssen Pharmaceutica NV (JAN), Belgium;
  • Novartis Pharma AG (NVS), Switzerland;
  • Sanofi-Aventis Recherche & Developpement (SARD), France;
  • Takeda Development Centre Europe Ltd. (Takeda), United Kingdom;
  • GlaxoSmithKline Research and Development Ltd. (GSK), United Kingdom;
  • Eli Lilly and Company Limited (Lilly), United Kingdom;
  • Pfizer Limited (Pfizer), United Kingdom;
  • Bristol-Myers Squibb Company Corp (BMS), United States;
  • Merck Kommanditgesellschaft auf Aktien (Merck), Germany;
  • Novo Nordisk A/S (Novo), Denmark;UCB Biopharma SPRL (UCB), Belgium;
  • AbbVie Inc (AbbVie), United States;
  • Ellegaard Göttingen Minipigs A/S (Ellegaard), Denkmark;
  • Covance Laboratories LTD (Covance), United Kingdom;
  • Teva Pharmaceutical Industries Limited (Teva), Israel.