APPEL A PROJET EUROPEEN - Recherche Clinique Paris Centre

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Transcript APPEL A PROJET EUROPEEN - Recherche Clinique Paris Centre

APPEL A PROJET EUROPEEN
« FP7-HEALTH-2013-innovation1
FP7-HEALTH-2013-innovation2»
PROJETS COLLABORATIFS
Objective *:
“Improving
the health of European citizens and
increasing the competitiveness and boosting the
innovative capacity of European health-related
industries and businesses while addressing global
health issues including emerging epidemics. Emphasis
will be put on translational research (translation of basic
discoveries in clinical applications including scientific
validation of experimental results) the development and
validation of new therapies, methods for health
promotion and prevention including promotion of child
health, healthy ageing, diagnostic tools and medical
technologies, as well as sustainable and efficient
healthcare systems ».
do cjoint « FP7-health-orientation paper. page 3
The research priorities * for 2013 are:
1-Brain research.
2- Antimicrobial drug resistance.
3 -Comparative effectiveness research.
4 Topics from other areas such as:
- developing personalised medicines approaches,
- cardiovascular research,
- safety and efficacy of therapies,
- cancer and public health research and
-a horizontal activity for translating research results into
innovative applications for health.
* Doc joint: « FP7-health-orientation paper. page 3 à 5 «
The innovation dimention* of the proposal will be sustened by :
(impact evaluation criteriae)
- SME-relevant research : strengthening the links between academia
and industry
-Support for clinical trial : testing the effetiveness of therapies
for traumatic brain injuries, cancer…
- Dissemination actions: improving the framework conditions for businness
to innovate in creating the single EU Patent, in harmonising the regulatory
framework, in improving access of SMEs to intellectual property protection.
- Open access in FP7.
-Docjoint « FP7-health-orientation paper. Page 5 et 6
1 Condition générale pour les participation::
Toute entreprise, université, centre de recherche, organisation ou particulier, légalement établi(e)
dans un pays quelconque, peut participer à un projet collaboratif (connu sous le nom d’action
indirecte)
2 Pays élligibles
•
Bien que les participants du 7e PC puissent en principe être basés n’importe où, diverses
catégories de pays peuvent disposer d’une éligibilité
•
ÉTATS MEMBRES – L’UE-27;
•
PAYS ASSOCIÉS – avec les accords de coopération scientifique et technologique qui ont impliqué
la contribution au budget du programme-cadre;
•
PAYS CANDIDATS – actuellement reconnus en tant que candidats pour une accession future;
•
PAYS TIERS – la participation d’organisations ou de particuliers établis dans des pays n’étant ni
des États membres, ni candidats ni associés, devrait également être justifiée en terme de
contribution accrue aux objectifs du 7e PC.
•
Visualisez la liste des pays partenaires au titre de la coopération internationale
•
Visualisez les Pays Associés
3 Consortium élligibles
•
ACTIONS INDIRECTES (PROJETS COLLABORATIFS) =FP7 HEALTH
•
Au moins trois entités juridiques (définies en tant qu’organisations ou chercheurs individuels
comme ci-dessus) doivent participer, chacune d’entre elle devant être établie dans un État
membre ou un pays associé, et deux d’entre elles ne pouvant être établies dans le même
État membre ou pays associé. Les trois entités juridiques doivent être indépendantes les unes
des autres conformément à l’article 6 du RFP, elles ne doivent donc ni être des filiales de la même
organisation ni des seconds l’une de l’autre.
Doc joint:CP (2 stages) general part 2012 Health-INNOVATION-1
Theme specific information:
1- Two-stage submission STAGE1 and STAGE2. Accessibility to STAGE 2 depends
on evaluation oF STAGE 1
Les soumissions s’effectueront sur ce site: https://www.epss-fp7.org/epss/
2. Two calls:
1- FP7-HEALTH-2013-INNOVATION-1 as main call with broader
topics of which many are tailored for SME participation.
2- FP7-HEALTH-2013-INNOVATION-2 as a specific call to boost SME participation
for innovative solutions in the health sector.
3.Duration of the project must be in line with the realistic planning of the project and
so, can be quite short (e.g.1-2 years), FP7-HEALTH-2013-INNOVATION-2 call
where the maximum project duration is limited to 3 years.
Référence Doc joint:CP (2 stages) general part 2012 Health-INNOVATION-1
Theme specific information (1)
A –Calendrier: calendrier 2013 non publié
Publication of call
call 20 July 2012 ?
Deadline for submission of stage 1
proposals
INNOVATION-1: 2 October 2011, ?
INNOVATION-2: 25 septembre 2012 2012 ?
Evaluation of stage one proposals
Decembre2012 ?
Deadline for submission of stage 2
proposals
February 2013 ?
Coordinators informed of results of
stage two proposals
April 2013 ?
B- Dossier constitué deux parties: « Part A » et « Part B »:
Part 1 and Part 2 sont à renseigner a STAGE1 and STAGE2 of the proposal
Part A : administration details that will be used in the evaluation and further
processiong of your proposal. * cf CP(2 stages) Annexes-health 2012INNOVATION-1 annex 3 page 14 à 23
PART B : detail of your work you attend to carry . * cf Annexes-health 2012INNOVATION-1 annex 4 page 24 à 46
Theme specific information (2)
Evaluation criteria* applicable to Collaborative project
proposals
S/T
QUALITYIMPLEMENTATIONIMPACT“
“Scientificand/or“
“Quality and
efficiency of the“
“Potential impact
through thetechnological
excellenceimplementationandthede
velopment, dissemination
and(relevanttothetopicsmanagemen
t“
”use of project results“
”addressed
by the call)
IMPLEMENTATION
Quality and efficiency
Of thr implementation and the
management
IMPACT
Potential impact through the
development, dissemination
and use of projects results.
Soundness of concept, and quality
of objectives␣Progress beyond the
state- of-the-art␣Quality and
effectiveness of the S/T
methodology and associated work
plan
Appropriateness of the management
structure and procedures␣Quality and
relevant experience of the individual
participants␣Quality of the consortium
as a whole (includingcomplementarity,
balance)␣Appropriatenessofthe
allocation and justification of the
resources to be committed (staff,
equipment …)
Contribution, at the European
[and/or international] level, to the
expected impacts listed in the work
programme under the relevant
topic/activity␣Appropriateness of
measures for the dissemination
and/or exploitation of project
results, and management of
intellectual property.
* cf Annexes-health 2012-INNOVATION-1 annex 2 page 5 à 13
Theme specific information (3)
2-TOPIQUES* (*fp7-health-2013-orientation-paper-page 9 à 46) :
0. HORIZONTAL TOPICS FOR COLLABORATIVE PROJECTS RELEVANT FOR THE WHOLE
OF THEME HEALTH
- FP7-HEALTH-2013-INNOVATION-2.:Boosting the translation of FP projects' results
into innovative applications for health.
1. BIOTECHNOLOGY, GENERIC TOOLS AND MEDICAL TECHNOLOGIES FOR HUMAN
HEALTH
-HEALTH.2013.1.2-1: Development of imaging technologies for therapeutic interventions in rare
diseases. .
-HEALTH.2013.1.3-1: Modelling toxic responses in case studies for predictive human
•
safety assessment. .
-HEALTH.2013.1.3-2: Innovative approaches to address adverse immune reactions to
biomedical devices, implants and transplant tissues-HEALTH.2013.1.3-3: Safety and efficacy
of therapeutic vaccines
-HEALTH.2013.1.3-4: Development of alternative in vitro, analytical, immunochemical,
and other test methods for quality control of vaccines.
1.4 stem cell research: HEALTH.2013.1.4-1. Controlling differentiation and proliferation in human
stem cells intended for therapeutic use.
2. TRANSLATING RESEARCH FOR HUMAN HEALTH:
2.1 INTEGRATING BIOLOGICAL DATA AND PROCESSES: LARGE-SCALE DATA
GATHERING, SYSTEMS BIOLOGY
- HEALTH.2013.2.1.1-1: Functional validation in animal and cellular models of
genetic determinants of diseases and ageing processes.
- HEALTH.2013.2.1.1-2: High impact research initiative on metagenomics for
personalised medicine approaches
2.2 RESEARCH ON THE BRAIN AND RELATED DISEASES, HUMAN
DEVELOPMENT AND AGEING
- HEALTH.2013.2.2.1-1: Prospective longitudinal data collection and Comparative
Effectiveness Research (CER) for traumatic brain injury (TBI).
-HEALTH.2013.2.2.1-2: Development of effective imaging tools for diagnosis,
monitoring and management of mental disorders28.
--HEALTH.2013.2.2.1-3: Paediatric conduct disorders characterised by aggressive
traits and/or social impairment: from preclinical research to treatment.
--HEALTH.2013.2.2.1-4: Patho-physiology and therapy of epilepsy and epileptiform
disorders.
--HEAL TH.2013.2.2.1-5:Understanding and controllingpain.
2.3 TRANSLATIONAL RESEARCH IN MAJOR INFECTIOUS DISEASES: TO
CONFRONT MAJORTHREATS TO PUBLIC HEALTH.
-HEALTH.2013.2.3.0-1: Innovation in vaccines..
-HEALTH.2013.2.3.1-1: Drugs and vaccines for infections that have developed or are
at the risk of developing significant anti-microbial resistance.
-HEALTH.2013.2.3.1-2: Stratified approaches to antibacterial and/or antifungal
treatment.
-HEALTH.2013.2.3.3-1: Clinical management of patients in severe epidemics.
-HEALTH.2013.2.3.4-1: Neglected infectious diseases of Central and Eastern Europe.
- HEALTH.2013.2.3.4-2: Drug development for neglected parasitic diseases. FP7-
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2.4 TRANSLATIONAL RESEARCH IN OTHER MAJOR DISEASES
HEALTH.2013.2.4.1-1: Investigator-driven treatment trials to
combat or prevent metastases in patients with solid cancer.
HEALTH.2013.2.4.1-2: Strengthening the cancer patient's immune system.
HEALTH.2013.2.4.1-3: Investigator-driven supportive and palliative care
clinical trials andobservationalstudies.
2.4.2 Cardiovascular diseases.
HEALTH.2013.2.4.2-1: Discovery research to reveal novel targets for
cardiovascular diseasetreatment.
HEALTH.2013.2.4.2-2: Comparative effectiveness research of existing
technologies for prevention, diagnosis and treatment of cardiovascular
diseases.
HEALTH.2013.2.4.2-3: Optimising lifestyle interactions in the prevention and
treatment of cardiovascular disease across the lifespan.
2.4.3 Diabetes and obesity: Closed 2013
20132.4.4 Rare diseases: Closed 2013
20132.4.5 Other chronic diseases: Closed 2013
3. OPTIMISING THE DELIVERY OF HEALTHCARE TO EUROPEAN CITIZENS
-HEALTH.2013.3.1-1: Comparative effectiveness research (CER) in health systems
and health services interventions.
-HEAL TH.2013.3.3-1:Social innovation3 fo rhealth promotion.
4. OTHER ACTIONS ACROSS THE HEALTH THEME
-HEALTH.2013.4.1-1: Supporting industrial participation in EU-funded research
in the Health sector.
-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.
-HEALTH.2013.4.1-3: Support for Presidency events: Organisation of supporting
actions and events associated to the Presidency of the European Union.
- HEALTH.2013.4.1-4: Preparing the future for health research and innovation.
-FP7-HEALTH.2013.4.1-5: Global initiative on gene-environment interactions
in diabetes/obesityinspecificpopulations.
-FP7-HEAL TH.2013.4.1-6: Mapping chronic non-communicable diseases research
activities.
4.2 RESPONDING TO EU POLICY NEEDS:
-HEALTH.2013.4.2-1: Investigator-driven clinical trials for off-patent medicines
using innovative, age-appropriate formulations and/or delivery systems.
-HEALTH.2013.4.2-2: Adverse drug reaction research.
.
-HEALTH.2013.4.2-3: New methodologies for clinical trials for small population
groups
Others mains points of the projects:
-Ethical issues: It is particularly important that applicants address the potential
ethical issues of their proposals, both in the proposed methodology and the
possible implications of the results.
-Use of animals in research: protocole on the protection and welfare of
animals
-Gender dimension: all projetc are encouraged to have balanced
participation of women and men
- Socio-economic dimension of research: account should be taken of
possible socio-economic impacts of research, including its intended and
unintended consequences and the inherent risks and opportunities.
-• Statistics in health research: the proposal must include and explain the
statical aspect.
- Funding schemes cf doc joint
Voir référence. doc ci joint « FP7-health-orientation paper. Page 7et 8
• LES ETAPES DU MONTAGE DU PROJET:
•
1- identifier le sujet de la recherche. Voir les questions à se poser dans ref jointe « le petit
guide d’aide au montage de projets FP7_CLORA »
2 - s’assurer de la conformité du sujet par rapport aux topiques proposés dans le FP7 Health
(cf liste des topiques jointes et détails des conditions de l’AO en fp7-health-2013orientation-paper-120402).
Pour cette étape nous pouvons proposer votre aide avec le PCN ( Point de contact Nationaux)
monsieur Nacer Boubenna INSERM, coordinateur du PCN. Étape clé+++
•
•
•
3 - Identifier les partenaires du consortium du projet: liens utiles
http://www.fitforhealth.eu/-Cordis général, réseau OSEO pour la recherche de PME pour le
consortium
https://cordis.europa.eu/partners/web/guest/home
4- Identifier les étapes du projets TRES PRECISEMENT cad déroulement dans le temps,
faisabilité, description des tâches de chacun des membres du consortium.
Ref: CP (2 stages) general part 2012 Health-INNOVATION-1
CP (2 stages) Annexes-health 2012-INNOVATION-1
5- Ecriture du projet (exigence éthique , de genre, de méthodo et statistique..). Coordinations
Inserm il y a possibilité d'être accompagnés (cf:http://dircom.inserm.fr/europe/linserm-vousaccompagne-d.html)
DATE DE REUNION et LIENS UTILES
Journée d’information sur tous les prochains appels
d’offres européens aura lieu le 15 juin prochain à
l’hôpital Cochin. Pôle Europe DRCD-PCN INSERM
(suivra planning et programme)
- CORDIS : http://cordis.europa.eu/fp7/health/
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Point de contact national santé PCN (France) comportant les
dernières informations utiles http://www.eurosfaire.prd.fr/7pc/health/
Nacer BOUBENNA Inserm +33 1 44 23 61 90
Lien du site Fitforhealth via le réseau OSEO pour la recherche de
PME pour le consortium : http://www.fitforhealth.eu/participate.aspx;
contact : [email protected]
Alix Pillot Pôle Europe (DRCD)-Assistance Publique-Hôpitaux de
Paris 10Bureau : +33 (0)1 40 27 46 13 Fax : +33 (0)1 44 84 17 88