Tool 2: Examples of Initiatives which Foster Public-Private Partnerships in Rare Disease and Complementary Areas

Published by

European Reference Network European Union Industry collaboration Network Rare Disease Research and Drug Development

This resource presents examples of programmes and structures which facilitate public private partnerships in rare disease or a complimentary area.

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Tool 3: What are ERNs?

Published by

Clinical Collaboration European Reference Network European Union Rare Disease Research Collaboration

This tool explains the origins of ERNs and highlights key resources on their conceptualisation, set-up and operations, including the legal documents on which they are based. It also points to reports and recommendations that analyse the achievements and added value of ERNs to date, indicating where there may be room for improvement, and to key resources showcasing the achievements of ERNs overall as well as where to learn more about the achievements of specific ERNs.

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Advanced Therapy Medicinal Products (ATMPs) Classification

Published by IRDiRC

Advanced Therapy ATMPs Classification Early Access Support European Union Regulatory Affairs

Companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is an advanced therapy medicinal product (ATMP). This is an opportunity for ATMP developers to receive confirmation that a medicine, which is based on genes, cells or tissues, meets the scientific criteria for defining an ATMP. The procedure can help developers to clarify the applicable regulatory framework since the beginning of the product development.

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EU Compassionate Use Programs

Published by IRDiRC

Clinical Development Compassionate Use Early Access Support EMA Compassionate Use European Union Orphan Drug Regulatory Affairs Research and Drug Development

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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European Joint Programme on Rare Diseases

Published by IRDiRC

European Union European Union Joint Programme for Rare Disease Network Research and Drug Development

The European Joint Programme Cofund is an instrument allowing high level strategic organization and performance of research activities in an organized and transversal manner.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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