Europe

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All SubjectsResearch and Drug Development

European Reference Networks

Published by IRDiRC

Research and Drug DevelopmentNetworkRare DiseaseEuropean Reference NetworkClinical CollaborationResearch Collaboration

Participating in research provides patients with access to cutting-edge treatments and benefit the population and the health services as a whole by leading to the development of more effective, high quality, cost-efficient treatments and healthcare delivery models. ERNs represent an unicum in the clinical and research worldwide collaborative panorama, indeed 24 ERNs span the over 6000 rare diseases by involving 300 EU HCPs and over 1000 specialized units in 25 EU countries

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Mechanism of Coordinated Access to OMPs

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsEUnetHTAHTA BodiesReimbursementOrphan MedicineMechanism of Coordinated Access to OMPs

Early dialogue with payers /Medev – MoCA provides a mechanism for European countries to collaborate on coordinated access to orphan medicines in a voluntary, dialogue-based approach, intended to create a fluid set of interactions between key stakeholders, across all aspects of a product

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EU Compassionate Use Programs

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentOrphan DrugEarly Access SupportEuropean UnionCompassionate UseEMA Compassionate Use

Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.

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Core Outcome Measures in Effectiveness Trials

Published by IRDiRC

Research and Drug DevelopmentClinical DevelopmentClinical Trial DesignEndpoint COMETOutcome MeasureEffectiveness Trial

The COMET (Core Outcome Measures in Effectiveness Trials) Initiative brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition, and are also suitable for use in clinical audit or research other than randomised trials.

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Biomarker Commercialization Review Tool

Published by Biomarker Commercialization (BIC) consortium

Research and Drug DevelopmentBiomarkerGuidelineBiomarker Commercialisation (BIC) Consortium

The BIC Review Tool is designed to improve communication, it allows an “inventors interview”-type of approach, in addition to being a checklist for Technology Transfer Offices and Researchers. It is designed to improve communication between the stakeholders involved in the commercialization process and to facilitate collaboration. The tool is therefore in a completely different format than the Biomarker Commercialization (BIC) Guide. All introductions and explanations are missing by intention since they can already be found in the BIC Guide, Best & Pitfall Practices handbook or the Regulatory Guide. 

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Biomarker Commercialization Guide

Published by Biomarker Commercialization (BIC) consortium

Research and Drug DevelopmentBiomarkerBiomarker DiscoveryBiomarker ValidationRegulatory Biomarker DevelopmentIVD AssayBiomarker Commercialisation

The Biomarker Commercialization (BIC) Guide supports academic researchers and SMEs when developing an in-vitro diagnostic biomarker invention to a commercial product. It provides guidance through the technology readiness levels (TRL) and covers the clinical, regulatory, and business aspects of the commercialization process. The tasks are described and partially supported by useful, downloadable documents.

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