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Research Pathways

Bringing gene and cell therapies from the lab bench to patients is a complex process and multiple pathways exists. The Research Pathways directory contains resources to help various stakeholders interested in therapy development navigate this process. Research Pathways is centred around the legal and regulatory aspects for cell and gene therapy development in Europe and further expanded to additional aspects. It is free to use and all resources in this database are categorised for improved searchability.

How to use Research Pathways  EuroGCT's Key Resources

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EuroGCT Resource

Manufacturing

  • EU and UK
  • 2022
  • EuroGCT
Advanced therapy medicinal products (ATMP) manufacturing concerns the industry-scale production of these therapies for supporting clinical development and commercialisation. This section provides an overview of the ATMP manufacturing processes, key terms, and related resources.

Theme

  • Tout afficher 7
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
EuroGCT Resource

Therapy Classification

  • EU and UK
  • 2022
  • EuroGCT
Therapy classification determines the legal mechanisms that govern the regulation of gene and cell therapies to ensure the quality, safety, and efficacy of these therapies on the EU market.

Theme

  • Tout afficher 5
  • Therapy classification
  • Legal classification
  • ATMPs
  • Not ATMPs: Human body elements for therapeutic applications
  • Not ATMPs: medical devices containing tissues and cells
EuroGCT Resource

Research and Innovation

    The development of innovative therapies starts with translating discoveries from basic research. This section explores the steps from fundamental to pre-clinical and clinical research underpinning the development of innovative gene and cell therapies.

    Theme

    • Tout afficher 7
    • Research and Innovation
    • Fundamental Research
    • Clinical research
    • Translational Science
    • Funding
    • Incentives
    • Early interaction with regulators
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