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STARS

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Strengthening training of academia in regulatory sciences and supporting regulat...

Strengthening training of academia in regulatory sciences and supporting regulatory scientific advice STARS Lack of specific relevant know-how in regulatory science delays the development of new treatment strategies or limits the chances that promising innovations will reach patients. STARS aims to improve the direct regulatory impact o... ver más

30/06/2022

BUNDESINSTITUT FUR...

2M€

Presupuesto del proyecto: 2M€

Líder del proyecto

BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPR... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Ver 22 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2022-06-30

SC1-HCO-05-2018: Strengthening regulatory sciences a...

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22 Participantes

BUNDESINSTITUT FUR ARZNEIMIT...

190.00K€ | Lider

MIRET Y COMPAÑIA

262.63K€ | Participante

INFARMED

22.50K€ | Participante

FAMHP

35.63K€ | Participante

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Duración del proyecto: 43 meses Fecha Inicio: 2018-11-20
Fecha Fin: 2022-06-30

Líder del proyecto

BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPR... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 2M€

Descripción del proyecto Lack of specific relevant know-how in regulatory science delays the development of new treatment strategies or limits the chances that promising innovations will reach patients. STARS aims to improve the direct regulatory impact of results obtained in medical research. Seventeen European countries are represented in the consortium through their national competent authorities, alongside academic and industry representatives, and associations with relevant experience. The work plan includes the development of a Comprehensive Inventory of existing support activities based on a detailed analysis of the currently established programmes. This analysis is also the basis for development of a Common Strategy to strengthen regulatory sciences and two curricula, the Core Curriculum specifying essential knowledge for the professional training of clinical scientists and the Comprehensive Curriculum defining relevant knowledge for specific post-graduate programmes. Three pilot projects aim (i) to transfer an identified best practice example for training programmes to other EEA countries, (ii) to implement a new support activity addressing a gap in regulatory knowledge of significant relevance and (iii) to implement the Comprehensive Curriculum. STARS will deliver consensual recommendations ensuring sustainable support of academic research and will propose additional support mechanisms based on a comprehensive analysis of needs. STARS has the objective and the potential to complement, coordinate and harmonise regulatory efforts among Member States and at European level to support academic health research for the benefit of patients. The aim is to reach academic researchers very early in the planning of relevant grant applications. A further aim is to strengthen regulatory knowledge in general by reaching clinical scientists during professional training and qualification.

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