Implementing decision 2013/713 - 2013/713/EU: Commission Implementing Decision of 29 November 2013 on setting up the European Clinical Research Infrastructure Network (ECRIN) as a European Research Infrastructure Consortium (ECRIN-ERIC) - Main contents

official title

COMMISSION IMPLEMENTING DECISION

of 29 November 2013

on setting up the European Clinical Research Infrastructure Network (ECRIN) as a European Research Infrastructure Consortium (ECRIN-ERIC)

(2013/713/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 723/2009 of 25 June 2009 on the Community legal framework for a European Research Infrastructure Consortium (ERIC) (1), and in particular point (a) of Article 6(1) thereof,

Whereas:

HAS ADOPTED THIS DECISION:

Article 1

• 1. 

  The European Clinical Research Infrastructure Network as a European Research Infrastructure Consortium named ECRIN-ERIC is hereby established.

• 2. 

  The Statutes of ECRIN-ERIC are set out in the Annex. These Statutes shall be kept up to date and made publicly available on the website of ECRIN-ERIC and at its statutory seat.

• 3. 

  The essential elements of the ECRIN-ERIC Statutes for which amendments shall require approval by the Commission in accordance with Article 11(1) of Regulation (EC) No 723/2009 are provided for in Articles 1, 2, 3, 11, 12, 14, 15, 19 and 20.

Article 2

This Decision shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 29 November 2013.

For the Commission

The President

José Manuel BARROSO

• (1) 

  OJ L 206, 8.8.2009, p. 1.

ANNEX I

STATUTES OF THE EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN-ERIC)

THE FEDERAL REPUBLIC OF GERMANY

THE KINGDOM OF SPAIN

THE FRENCH REPUBLIC

THE ITALIAN REPUBLIC

THE PORTUGUESE REPUBLIC

Hereinafter referred to as ‘the Founding Members’

DESIRING to strengthen Europe’s and the Founding Member countries’ position in clinical research in the world, and to intensify cooperation across national boundaries;

CONSIDERING that multinational clinical research is currently hampered by the fragmentation of health and legislative systems in Europe, an obstacle for multinational cooperation in investigator driven, as well as industry-sponsored clinical research (particularly in the biotechnology and medical device sectors), European countries must unlock latent scientific potential and access to patients and expertise, thus strengthening the competitiveness of Europe in clinical science and its attractiveness for the development of preventive, diagnostic and therapeutic procedures — this is of particular importance for rare diseases, paediatrics, personalised treatments, for the development of biotherapy, and for independent clinical trials that are pivotal instruments for evidence-based medicine;

BUILDING on the ESFRI roadmap that identified the European Clinical Research Infrastructure Network (ECRIN) as the distributed infrastructure supporting, based on scientific excellence, clinical research in Europe through information, consulting and services to investigators and sponsors in multinational studies, acting through correspondents hosted in national clinical research hubs and networks, also contributing to the structuring of national infrastructures,...

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