Objectif We propose an academic & industrial partnership to facilitate safe and effective delivery of new advanced therapy medicines within the framework of the relevant EU regulations which our previous FP7 funded project have identified as creating unanticipated barriers to development of this field. Over 80% of advanced therapy medicines (ATMPs) trials in the EU are academic investigator led and sponsored. Many ATMPs are not making it to first-in-man trials due to the difficulties of academic manufacture to GMP compliance and the variation of application of the Directives between EU MS. We will deliver a supporting programme of resources to academic trialists to streamline their development programmes, enhance compliance with GMP requirements, develop industrial partnerships for improved manufacture and scale-up and establish the first university certified training programmes in cell/tissue engineering to address the critical shortage in scientific/technical/regulatory staff in this newly expanding field across the EU.The future supply of successful ATMPs to EU citizens will require partnerships between academic GMP facilities, contract ATMP manufacturers (CMOs) and the biopharma industry and this project will deliver the necessary support and training structure to create this partnership. The need for this project has been identified from the impact assessment part of our current FP7 project, “Academic GMP” and the culmination of the project will be a scientific analysis of the effect of the programme on the impact of the legislation relevant to ATMP development and provision across the EU. Champ scientifique medical and health sciencesmedical biotechnologytissue engineering Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Thème(s) HEALTH.2013.4.1-2 - Interactions between EU legislation and health research and/or innovation and the effects of its application and implementation on health research and/or innovation Appel à propositions FP7-HEALTH-2013-INNOVATION-1 Voir d’autres projets de cet appel Régime de financement CSA-SA - Support actions Coordinateur UNIVERSITY COLLEGE LONDON Contribution de l’UE € 180 823,00 Adresse GOWER STREET WC1E 6BT LONDON Voir sur la carte Type d’activité Higher or Secondary Education Establishments Contact administratif Mark Lowdell (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée Participants (7) Trier par ordre alphabétique Trier par contribution de l’UE Tout développer Tout réduire KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN Allemagne Contribution de l’UE € 74 040,00 Adresse ISMANINGER STRASSE 22 81675 Muenchen Voir sur la carte Région Bayern Oberbayern München, Kreisfreie Stadt Type d’activité Higher or Secondary Education Establishments Contact administratif Renate Rädlein (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée UNIVERSITAIR MEDISCH CENTRUM UTRECHT Pays-Bas Contribution de l’UE € 63 130,00 Adresse HEIDELBERGLAAN 100 3584 CX Utrecht Voir sur la carte Région West-Nederland Utrecht Utrecht Type d’activité Higher or Secondary Education Establishments Contact administratif Susan Zwaagstra (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée MEDIZINISCHE HOCHSCHULE HANNOVER Allemagne Contribution de l’UE € 45 368,00 Adresse Carl-Neuberg-Strasse 1 30625 Hannover Voir sur la carte Région Niedersachsen Hannover Region Hannover Type d’activité Higher or Secondary Education Establishments Contact administratif Ulrike Koehl (Prof.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée UNIVERSITY OF NEWCASTLE UPON TYNE Royaume-Uni Contribution de l’UE € 41 088,00 Adresse KINGS GATE NE1 7RU Newcastle Upon Tyne Voir sur la carte Région North East (England) Northumberland and Tyne and Wear Tyneside Type d’activité Higher or Secondary Education Establishments Contact administratif Fiona Airey (Mrs.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée KLINIKUM DER UNIVERSITAET REGENSBURG Allemagne Contribution de l’UE € 20 330,00 Adresse FRANS JOSEF STRAUSS ALLEE 11 93053 Regensburg Voir sur la carte Région Bayern Oberpfalz Regensburg, Kreisfreie Stadt Type d’activité Higher or Secondary Education Establishments Contact administratif Andrea Hauser (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée ACADEMISCH ZIEKENHUIS LEIDEN Pays-Bas Contribution de l’UE € 29 853,00 Adresse ALBINUSDREEF 2 2333 ZA Leiden Voir sur la carte Région West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek Type d’activité Higher or Secondary Education Establishments Contact administratif Sonja Croes-De Bruin (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée LONZA NETHERLANDS BV Pays-Bas Contribution de l’UE € 42 800,00 Adresse OXFORDLAAN 70 6229 EV Maastricht Voir sur la carte Région Zuid-Nederland Limburg (NL) Zuid-Limburg Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Cedric Volanti (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée
