EUCELLEX
Cell-based regenerative medicine: new challenges for EU legislation and governance
| Coordinatore | INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)
Organization address
address: 101 Rue de Tolbiac contact info |
| Nazionalità Coordinatore | France [FR] |
| Totale costo | 559˙840 € |
| EC contributo | 500˙000 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2013-INNOVATION-1 |
| Funding Scheme | CSA-SA |
| Anno di inizio | 2013 |
| Periodo (anno-mese-giorno) | 2013-10-01 - 2016-09-30 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)
Organization address
address: 101 Rue de Tolbiac contact info |
FR (PARIS) | coordinator | 108˙739.00 |
| 2 |
KOZEP-EUROPAI EGYETEM
Organization address
address: Nador utca 9 contact info |
HU (BUDAPEST) | participant | 53˙029.00 |
| 3 |
FONDATION NATIONALE SCIENCES POLITIQUES
Organization address
address: RUE SAINT GUILLAUME 27 contact info |
FR (PARIS CEDEX 07) | participant | 53˙004.00 |
| 4 |
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
Organization address
address: University Offices, Wellington Square contact info |
UK (OXFORD) | participant | 52˙984.00 |
| 5 |
KATHOLIEKE UNIVERSITEIT LEUVEN
Organization address
address: Oude Markt 13 contact info |
BE (LEUVEN) | participant | 52˙911.00 |
| 6 |
Medizinische Universitaet Graz
Organization address
address: AUENBRUGGERPLATZ 2 contact info |
AT (GRAZ) | participant | 52˙822.00 |
| 7 |
ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING MCGILL UNIVERSITY
Organization address
address: SHERBROOKE STREET WEST 845 contact info |
CA (MONTREAL) | participant | 42˙350.00 |
| 8 |
GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER
Organization address
address: Welfengarten 1 contact info |
DE (HANNOVER) | participant | 42˙217.00 |
| 9 |
LEGAL PATHWAYS BV
Organization address
address: KLAPHEKLAAN 8 contact info |
NL (AERDENHOUT) | participant | 41˙944.00 |
Mappa
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Obiettivo del progetto (Objective)
'This proposal aims at collecting and analysing facts and figures in order to assess the current legislation on the therapeutic use of somatic cells, and to bridge it with the research infrastructure capacity building. Although EU has adopted 3 Directives on Tissues and cells between 2004 and 2006 to harmonise the procurement, storage and use of cells for therapeutic use in Europe, countries have implemented these directives in very different ways. Furthermore, research has been partially covered by the initial regulation, calling into question the match between regulation and practices that will develop in the near future, in particular with the emergence of European research infrastructures. Finally many changes have occurred in the scientific, legal and institutional environment of cell use, leading to a necessary update of this regulation with regards to its implementation in national legislation and its impact on research practice and innovation. Two domains are at stake: research (infrastructures) and medical practice/public health measures (cells). The therapeutic use of cells is regulated by EU law whereas its research counterpart is mainly depending on national laws and regulations. This gap calls for a coordinated action in order to optimize the translational process, since the full pipeline is not coherently taken into account in current legislations. To achieve these objectives, our project relies on a coherent consortium of experts in the fields of cells therapies, cells banks and translational biomedicine, having strong expertise in law and/ or in governance issues. After 36 months the project will deliver evidence about the contemporary practices around cells and will design a picture of the “market” and its distribution between the public and private sector. The project will thus help the Commission in the regulatory choices covering the use of human cells for therapeutic purposes and to foster the innovation potential of related research activities.'