CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.
Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .
Livrables
A specific website for the project as described in task 73 will be developed A document including screenshots and the link to the website will be generated
Halfway through the project an assessment of the degree of fulfilment of the objectives of the project will be carried out and reported in this deliverable
Report on the psychosocial impact (s’ouvre dans une nouvelle fenêtre)A report including the assessment of the social impacts will be elaborated
Position paper in One health area (s’ouvre dans une nouvelle fenêtre)Paper for policy makers and other stakeholders in the area on One health. The position paper will include recommendations for the area based in the experience of RBDCOV project.
Report on the participant's centric design protocol for RBDCOV (s’ouvre dans une nouvelle fenêtre)Description of the main points that have been considered and discussed during the preparation of the protocol
Notification of first patient treated in children and adolescents clinical trial (s’ouvre dans une nouvelle fenêtre)Report on a meeting with the VACCELERATE project, including concrete plan for collaboration (s’ouvre dans une nouvelle fenêtre)
Upon availability of clinical trial data that would allow further evaluation of the developed vaccine candidates in Phase II clinical trials RBDCOV will organise a meeting with the VACCELERATE project InfoVaccelerateEU to present their findings and seek advice on how to best make use of existing clinical trial infrastructure developed in the VACCELERATE project VaccelerateEU to accelerate further clinical development of the vaccine candidates
Final Business plan for RBDCOV (s’ouvre dans une nouvelle fenêtre)A document with the final business plan will be focused on the strategy for commercialisation and exploitation of the vaccines after the end of the project. The document will also include the business plan for any other commercial result of the project.
Regulatory strategy report (s’ouvre dans une nouvelle fenêtre)The regulatory report will define the regulatory pathway and milestones for the optimal development of the vaccine including also CMC preclinical and clinical aspects and considering EMA Fast track procedures
Report on communication and dissemination activities (s’ouvre dans une nouvelle fenêtre)A detailed list of dissemination activities carried out halfway through the project with assessment of their impact the degree of compliance with the plan and a description of foreseen dissemination activities until the end of the projectThe report will be updated in month 24 and 30
Children and adolescents initiation package (s’ouvre dans une nouvelle fenêtre)The deliverable will be submitted before the enrolment of the first participant and will include the registration number of the clinical study, final version of the study protocol (approved by regulators and ethical committees) and the copies of the document that demonstrate the approval of the trial in the correspondent sites
Children and adolescents Mid-term recruitment report (s’ouvre dans une nouvelle fenêtre)A report including the number of participants included at each clinical site until the end of month 5 of the clinical trial where the achievement of the 50% participants is expected
Data Management Plan for RBDCOV project (s’ouvre dans une nouvelle fenêtre)A data management plan addressing all the aspects inlcuded in the template for data management plans avaliable for Horizon Europe projects will be submitted as deliverable This DMP will be aligned with the draft included in the submission of the Grant Agreement and will be updated accordingly during the project duration
Plan for the Exploitation and Dissemination of Results (PEDR) (s’ouvre dans une nouvelle fenêtre)This document will describe in detail the project communication dissemination and exploitation strategy in all of its components objectives audiences channels actions results IP management and tools
Notification of first patient treated in Variants' clinical trial (s’ouvre dans une nouvelle fenêtre)Notification of first patient treated in Variants clinical trial
Report on the early engagement with the European Medical Agency (s’ouvre dans une nouvelle fenêtre)A brief report on a consultation with the European Medical Agency EMA to ensure that regulatory aspects for the clinical development and evaluation of the candidate compounds are properly addressed and embedded in the study design Scientific advice and protocol assistance European Medicines Agency europaeu Requesting scientific advice or protocol assistance from EMA European Medicines Agency europaeu
Report on the status of posting results of the vaccine in children (s’ouvre dans une nouvelle fenêtre)Summary of the posting results in the applicable registry.
Mid-term recruitment report of the variant vaccine (s’ouvre dans une nouvelle fenêtre)A report including the number of participants included at each clinical site until the end of month 5 of the clinical trial where the achievement of the 50 participants is expected
MA&P strategy report (s’ouvre dans une nouvelle fenêtre)The market access and pricing strategy for the vaccines developed by HIPRA will be described in this report including the potential risks and markets for the commercialisation with a clear OH strategy
Quality assurance guidelines and procedures (s’ouvre dans une nouvelle fenêtre)A set of quality assurance principles
Report on the status of posting results of the variant vaccine (s’ouvre dans une nouvelle fenêtre)A summary of the posting results in the applicable registry
Biological sample logs and database with clinical information (s’ouvre dans une nouvelle fenêtre)This deliverable will account for the generation of a comprehensive database including sample information and clinical information according to the data management plan.
Toolbox with the information documents co-developed with the CAB (s’ouvre dans une nouvelle fenêtre)Including info sheets, informed consent, etc.
Target communication tools (s’ouvre dans une nouvelle fenêtre)How to communicate complex information into a laymans language Infographics among other tools will be summarised in the deliverable
Final assessment of the project (s’ouvre dans une nouvelle fenêtre)At the end of the project, a final assessment of the degree of fulfilment of the objectives of the project.
Includes details around database workflows external vendors requirements for reconciliations and details surrounding planned formal analyses including final database lock
Droits de propriété intellectuelle
Numéro de demande/publication:
EU
018704530
Date:
2022-05-17
Demandeur(s):
LABORATORIOS HIPRA SA
Numéro de demande/publication:
EU
018704520
Date:
2022-05-17
Demandeur(s):
LABORATORIOS HIPRA SA
Numéro de demande/publication:
20
22060941
Date:
2022-04-25
Demandeur(s):
HIPRA SCIENTIFIC SL
Numéro de demande/publication:
20
22060941
Date:
2022-04-25
Demandeur(s):
LABORATORIOS HIPRA SA
Numéro de demande/publication:
20
22060942
Date:
2022-04-25
Demandeur(s):
LABORATORIOS HIPRA SA
Numéro de demande/publication:
20
22060942
Date:
2022-04-25
Demandeur(s):
HIPRA SCIENTIFIC SL
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