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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

Descripción del proyecto

Estudio paneuropeo sobre la seguridad de los medicamentos durante el embarazo

El proyecto ConcePTION, financiado con fondos europeos, se propone generar un cambio de paradigma en los estudios sobre la seguridad de los medicamentos durante el embarazo. El consorcio incluye a líderes experimentados para la gestión de redes de asociaciones públicas y privadas, conexiones con iniciativas similares en otras partes del mundo y la reevaluación de datos de proyectos anteriores de la Comisión Europea. Los objetivos del proyecto incluyen la creación de un ecosistema en la Unión Europea sostenible y no patentado de partes interesadas públicas y privadas, mujeres embarazadas e investigadores para generar y difundir pruebas sobre la exposición a medicamentos durante el embarazo y la lactancia. En la investigación se emplearán modelos para la predicción de la transferencia de medicamentos a través de la leche materna, el análisis de datos de biobancos, la cuantificación de medicamentos en la leche materna y la recopilación de datos digitales y muestras directamente de mujeres embarazadas.

Objetivo

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.

Régimen de financiación

RIA - Research and Innovation action

Coordinador

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Aportación neta de la UEn
€ 2 486 436,44
Dirección
HEIDELBERGLAAN 100
3584 CX Utrecht
Países Bajos

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Región
West-Nederland Utrecht Utrecht
Tipo de actividad
Higher or Secondary Education Establishments
Enlaces
Coste total
€ 2 581 436,45

Participantes (66)