Hola,
¿eres nuevo aquí?

Regístrate gratis y conecta tu empresa con financiación pública, partners y proyectos.

Tengo cuenta

Regístrate

Ver video

ERAMET

Financiado

Ecosystem for rapid adoption of modelling and simulation METhods to address regu...

Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines ERAMET will provide an integrated approach for developers and regulators’ decision-making for paediatric and orphan drugs, centred on the drug development questions. This will constitute a transparent ecosystem for drug developmen... ver más

31/12/2027

UNamur

4M€

Presupuesto del proyecto: 4M€

Líder del proyecto

UNIVERSITE DE NAMUR ASBL No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Ver 17 Participantes

Financiación concedida El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2023-11-17

HORIZON-HLTH-2023-IND-06-04: Modelling and simulation to address... Expected Outcome:This topic aims at supporting activities that are enabling or contributing to one o...

I+D

Cerrada hace 1 año

0% 100% 100%

17 Participantes

UNamur

987.75K€ | Lider

UNICT

500.31K€ | Participante

AGENCIA ESPAÑOLA DE MEDICAME...

N.D. | Participante

CERTARA UK LIMITED

N.D. | Participante

Conecta tu I+D

¿Tienes un proyecto y buscas un partner? Gracias a nuestro motor inteligente podemos recomendarte los mejores socios y ponerte en contacto con ellos. Te lo explicamos en este video

Proyectos interesantes

GETREAL Incorporating real-life clinical data into drug development 17M€ Cerrado

PLEC2021-007614 Gemelos digitales cardíacos personalizados para mejorar el d... 410K€ Cerrado

DDMORE Drug Disease Model Resources 23M€ Cerrado

UTILIZACIÓN DEL REAL-WORLD DATA PARA LA EVALU... UTILIZACIÓN DEL REAL-WORLD DATA PARA LA EVALUACIÓN DE LA EFE... 195K€ Rechazado

PRE2021-100416 MEDICINA INTERCEPTIVA, DESCUBRIMIENTO DE DIANAS Y REUTILIZAC... 101K€ Cerrado

UTILIZACIÓN DEL REAL-WORLD DATA PARA LA EVALU... UTILIZACIÓN DEL REAL-WORLD DATA PARA LA EVALUACIÓN DE LA EFE... 231K€ Rechazado

Duración del proyecto: 49 meses Fecha Inicio: 2023-11-17
Fecha Fin: 2027-12-31

Líder del proyecto

UNIVERSITE DE NAMUR ASBL No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 4M€

Descripción del proyecto ERAMET will provide an integrated approach for developers and regulators’ decision-making for paediatric and orphan drugs, centred on the drug development questions. This will constitute a transparent ecosystem for drug development and assessment, that will facilitate the adoption of modelling and simulation (M&S) methods and related data types (including real word data such as registries and electronic healthcare data). The overall objective of ERAMET is to provide and implement a framework for establishing the credibility of M&S methods and related results as sources of evidence within regulatory procedures. The ecosystem proposed by ERAMET will be based on three pillars: (1) A repository connecting questions, data and methods. (2) The development and validation of high-quality standards for data and analytical methods (including M&S and hybrid approaches). These will cover computational M&S, digital twins, AI, hybrid approaches, standard statistics and pharmacometrics, as analytical methods and alternative data types and sources such as RWD, eHealth data, registries, historical regulatory submissions, scientific and (non)clinical trials). (3) An AI-based platform that will automate and optimise the data collection, formatting and modelling and simulation analysis and implement the credibility assessment. As part of ERAMET, the ecosystem will be applied to five use-cases including paediatric extrapolation and characterisation of drug benefit/risk in 4 groups of rare diseases, namely ataxia, transfusion dependent haemoglobinopathies, bronchopulmonary dysplasia, and degenerative neuromuscular. Each of the use-case is planned to lead to submission and regulatory approval of at least one validated M&S tool via the EMA qualification procedure. Training will be proposed to familiarise regulatory assessors, drug developers and clinical researchers with this new approach.

Conecta tu I+D

Entra hoy

¿Olvidó su contraseña?

Financiación

Empresas

CTIs/Universidades

Proyectos

Investigadores