CORDIS
EU research results

CORDIS

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Strengthening training of academia in regulatory sciences and supporting regulatory scientific advice (STARS)

Project information

Grant agreement ID: 825881

Status

Ongoing project

  • Start date

    1 January 2019

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.6.

  • Overall budget:

    € 1 986 000

  • EU contribution

    € 1 986 000

Coordinated by:

BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE

Germany

Objective

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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Coordinator

BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE

Address

Kurt Georg Kiesinger Allee 3
53175 Bonn

Germany

Activity type

Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)

EU Contribution

€ 190 000

Participants (20)

DEUTSCHES ZENTRUM FUER LUFT - UND RAUMFAHRT EV

Germany

EU Contribution

€ 680 000

BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL

Germany

EU Contribution

€ 190 000

AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN

Netherlands

EU Contribution

€ 120 000

ORSZAGOS GYOGYSZERESZETI ES ELELMEZES-EGESZSEGUGYI INTEZET

Hungary

EU Contribution

€ 52 500

THE MEDICINES AUTHORITY

Malta

EU Contribution

€ 82 500

LAAKEALAN TURVALLISUUS-JA KEHITTAMISKESKUS

Finland

EU Contribution

€ 112 500

AGENZIA ITALIANA DEL FARMACO

Italy

EU Contribution

€ 57 000

AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS

Spain

EU Contribution

€ 75 000

INFARMED - AUTORIDADE NACIONAL DO MEDICAMENTO E PRODUTOS DA SAUDE IP

Portugal

EU Contribution

€ 22 500

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

United Kingdom

EU Contribution

€ 40 875

HEALTH PRODUCTS REGULATORY AUTHORITY

Ireland

EU Contribution

€ 37 500

LAKEMEDELSVERKET

Sweden

EU Contribution

€ 86 250

VALSTYBINE VAISTU KONTROLES TARNYBAPRIE LIETUVOS RESPUBLIKOS SVEIKATOS APSAUGOS MINISTERIJOS

Lithuania

EU Contribution

€ 42 500

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS

Belgium

EU Contribution

€ 35 625

STATNI USTAV PRO KONTROLU LECIV

Czechia

EU Contribution

€ 22 125

URZAD REJESTRACJI PRODUKTOW LECZNICZYCH, WYROBOW MEDYCZNYCH I PRODUKTOW BIOBOJCZYCH

Poland

EU Contribution

€ 53 250

ZALU VALSTS AGENTURA

Latvia

EU Contribution

€ 14 625

OSTERREICHISCHE AGENTUR FUR GESUNDHEIT UND ERNAHRUNGSSICHERHEIT GMBH

Austria

EU Contribution

€ 33 750

AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE

France

EU Contribution

€ 30 000

THE EUROPEAN MEDICINES AGENCY

Netherlands

EU Contribution

€ 7 500

Project information

Grant agreement ID: 825881

Status

Ongoing project

  • Start date

    1 January 2019

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.6.

  • Overall budget:

    € 1 986 000

  • EU contribution

    € 1 986 000

Coordinated by:

BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE

Germany