Livrables
Migration
Operational portal to allow for internal team informationMigration
Press releases (various releases during project)Migration
Project meetings scheduled and organizedMigration
Organisation of closing eventMigration
Create ADAPT SMART infographicMigration
Management of IPMigration
Project templates and materials for communicationMigration
Migration
Position paper on the impact of adaptive licencing and adaptive access on IP and regulatory data protection periods and recommendationsMigration
Update D1.02 – Document- analysis of already completed IMI and non-IMI projects and their outputsMigration
Short report-horizon scanning of future IMI and non-IMI projects with release of a summary of the findingsMigration
Document-analysis of already completed IMI and non-IMI projects and their outputsMigration
Select methods, toolset (such as the Janus program) and datasets to perform scenario studies in order to facilitate stakeholder’s engagementMigration
Detailed work plan for each deliverable including staffing 3Migration
Detailed work plan for each deliverable including staffing 2Migration
Collaborative research proposals based on gap analysisMigration
Matrix that contrasts decision points in current vs. future processes by stakeholder groups and implications for a roadmap for implementation. (workshop in M7)Migration
Inventory/Paper on the available managed entry agreements, including pricing models and their experiences as judged by the different stakeholdersMigration
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)Migration
Map of the different transition/engagement moments with stakeholders, and identify the information and data needs of these stakeholders at each of these momentsMigration
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)Migration
Six-monthly reports on project progress and completion (first in M6, then every 6 months)Migration
Briefing documents during project about EMA pilots to relevant leads of the working groups in the projectMigration
Detailed work plan for each deliverable including staffing 1Migration
External communications plan (and updated)Migration
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)Migration
Recommendations on applicability of managed entry agreements and pricing arrangements to possible adaptive scenariosMigration
Review/paper on the ethical and legal aspects of prescribing and use by target populationsMigration
Points to consider document on ethical and legal aspects of adaptive decision-making and recommendations on how these can be addressedMigration
Glossary with agreed operational definitions of the terms used in international literatureMigration
Inventory and analysis of increased uncertainties for patients and other stakeholders and the issues these raiseMigration
Reports to IMI (first in M18, then M30)Migration
Detailed project plans/tools for use by the consortiumMigration
Publications
Auteurs:
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
Publié dans:
Clinical Pharmacology & Therapeutics, 2018, ISSN 0009-9236
Éditeur:
Nature Publishing Group
DOI:
10.1002/cpt.1121
Auteurs:
Jacoline C. Bouvy, Claudine Sapede, Sarah Garner
Publié dans:
Frontiers in Pharmacology, Numéro 9, 2018, ISSN 1663-9812
Éditeur:
Frontiers Media S.A.
DOI:
10.3389/fphar.2018.00280
Auteurs:
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
Publié dans:
Nature Reviews Drug Discovery, 2018, ISSN 1474-1776
Éditeur:
Nature Publishing Group
DOI:
10.1038/nrd.2018.90
Auteurs:
C. Sapede
Publié dans:
Value and Outcomes Spotlight, 2017, Page(s) 11-13
Éditeur:
Ispor
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