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CORDIS - Resultados de investigaciones de la UE
CORDIS

Accelerated Development of Appropriate Patient Therapies: a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes - Sofia ref.: 115890

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

Identification of legal constraints for MAPPs (se abrirá en una nueva ventana)

Migration

Position paper on the impact of adaptive licencing and adaptive access on IP and regulatory data protection periods and recommendations (se abrirá en una nueva ventana)

Migration

Update D1.02 – Document- analysis of already completed IMI and non-IMI projects and their outputs (se abrirá en una nueva ventana)

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Short report-horizon scanning of future IMI and non-IMI projects with release of a summary of the findings (se abrirá en una nueva ventana)

Migration

Document-analysis of already completed IMI and non-IMI projects and their outputs (se abrirá en una nueva ventana)

Migration

Select methods, toolset (such as the Janus program) and datasets to perform scenario studies in order to facilitate stakeholder’s engagement (se abrirá en una nueva ventana)

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Detailed work plan for each deliverable including staffing 3 (se abrirá en una nueva ventana)

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Detailed work plan for each deliverable including staffing 2 (se abrirá en una nueva ventana)

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Collaborative research proposals based on gap analysis (se abrirá en una nueva ventana)

Migration

Matrix that contrasts decision points in current vs. future processes by stakeholder groups and implications for a roadmap for implementation. (workshop in M7) (se abrirá en una nueva ventana)

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Inventory/Paper on the available managed entry agreements, including pricing models and their experiences as judged by the different stakeholders (se abrirá en una nueva ventana)

Migration

Proposal for pragmatic operational criteria for the respective decision(s) to use the MAPPs pathway, the timing and the stakeholders needed for this decision. (workshop in M6, briefing document M4) (se abrirá en una nueva ventana)

Migration

Map of the different transition/engagement moments with stakeholders, and identify the information and data needs of these stakeholders at each of these moments (se abrirá en una nueva ventana)

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Gap analysis and where appropriate recommendations for projects addressing enablers of decision making in an adaptive environment (e.g. managing uncertainties at HTA level). (interim: M6, M18) (se abrirá en una nueva ventana)

Migration

Six-monthly reports on project progress and completion (first in M6, then every 6 months) (se abrirá en una nueva ventana)

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Briefing documents during project about EMA pilots to relevant leads of the working groups in the project (se abrirá en una nueva ventana)

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Detailed work plan for each deliverable including staffing 1 (se abrirá en una nueva ventana)

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External communications plan (and updated) (se abrirá en una nueva ventana)

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Report with recommendations on current tools and systems to guide the appropriate use by the targeted patient groups, both at the European and national level (also input for D3.09). (workshop in M16) (se abrirá en una nueva ventana)

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Recommendations on applicability of managed entry agreements and pricing arrangements to possible adaptive scenarios (se abrirá en una nueva ventana)

Migration

Review/paper on the ethical and legal aspects of prescribing and use by target populations (se abrirá en una nueva ventana)

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Points to consider document on ethical and legal aspects of adaptive decision-making and recommendations on how these can be addressed (se abrirá en una nueva ventana)

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Glossary with agreed operational definitions of the terms used in international literature (se abrirá en una nueva ventana)

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Inventory and analysis of increased uncertainties for patients and other stakeholders and the issues these raise (se abrirá en una nueva ventana)

Migration

Reports to IMI (first in M18, then M30) (se abrirá en una nueva ventana)

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Detailed project plans/tools for use by the consortium (se abrirá en una nueva ventana)

Migration

Publicaciones

Medicines Adaptive Pathways to Patients: Why, when and how to engage? (se abrirá en una nueva ventana)

Autores: Hans-Georg Eichler, Nicola Bedlington, Mathieu Boudes, Jacoline C. Bouvy, André W. Broekmans, Francesca Cerreta, Stuart D. Faulkner, Sue Forda, Angelika Joos, Yann Le Cam, Mark Mayer, Vinciane Pirard, Solange Corriol-Rohou
Publicado en: Clinical Pharmacology & Therapeutics, 2018, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.1121

Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe (se abrirá en una nueva ventana)

Autores: Jacoline C. Bouvy, Claudine Sapede, Sarah Garner
Publicado en: Frontiers in Pharmacology, Edición 9, 2018, ISSN 1663-9812
Editor: Frontiers Media S.A.
DOI: 10.3389/fphar.2018.00280

The evolution of adaptiveness: balancing speed and evidence (se abrirá en una nueva ventana)

Autores: Hans-Georg Eichler, Richard Barker, Nicola Bedlington, Jacoline C. Bouvy, André W. Broekmans, Anna Bucsics, Francesca Cerreta, Solange Corriol-Rohou, Alicia Granados, Yann Le Cam, Ad Schuurman
Publicado en: Nature Reviews Drug Discovery, 2018, ISSN 1474-1776
Editor: Nature Publishing Group
DOI: 10.1038/nrd.2018.90

Patient Access in the Context of Adaptive Pathways for Medicines: What Could Make It Work?

Autores: C. Sapede
Publicado en: Value and Outcomes Spotlight, 2017, Página(s) 11-13
Editor: Ispor

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