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 (ConcePTION)

Framework: Horizon 2020 — Societal Challenges
Programme: Health, demographic change and wellbeing
Theme: Public-private partnerships
Destination: Innovative Medicines Initiative 2
Action type: Research and Innovation actions
Partnership: IMI2 (Art-187)
Countries involved: Austria,Germany,Italy,Italy,South Africa,Germany,Israel,Spain,Ireland,Italy,Italy,Belgium,Switzerland,Norway,Türkiye,Belgium,Poland,Sweden,Sweden,Switzerland,Switzerland,Belgium,Switzerland,Belgium,Finland,Croatia,North Macedonia,Belgium,France,France,France,France,Czechia,Netherlands,Netherlands,Netherlands,United States,Netherlands,Netherlands,Netherlands,United Kingdom,United Kingdom,United Kingdom,United Kingdom,Denmark,United Kingdom,United Kingdom,United Kingdom,United Kingdom,United Kingdom,Denmark,United Kingdom,United Kingdom,Denmark
Call: ConcePTION – Continuum of Evidence from Pregnancy Exposures, Reproductive Toxicology and Breastfeeding to Improve Outcomes Now (H2020-JTI-IMI2-2017-13-two-stage, 2017)
Start date: 2019-04-01
End date: 2024-03-31
Duration (months): 60.0
Total project cost (EUR): 28782491.01
EU funding (EUR): 15299991.0
Participants: 67
Project status: SIGNED

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.

Keywords: pregnancy and lactation pharmacovigilance,outcome measures,predictive models,biobank