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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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Showing 10 of 91
EuroGCT Resource

Data sharing / Open data

  • EU and UK
  • 2023
  • Inserm, University of Toulouse Paul Sabatier and EuroGCT
Data sharing is the act of providing data or access to data from a data holder to a data user, for a defined processing purpose, subject to applicable technical, financial, legal, or organisational use requirements. Open data refers to making available research data or publications without restrictions regarding the reuses.

Theme

  • Show all 2
  • Data sharing / Open Data
  • Ethics
EuroGCT Resource

Data Protection Main Principles

  • EU and UK
  • 2023
  • NOVA University of Lisbon, Tilburg University and EuroGCT
The main principles of data protection include: Self-determination; Lawfulness, fairness and transparency; Purpose limitation; Data minimization; Accuracy; Storage duration limitation; Integrity, security and confidentiality; FAIR principles (findable, accessible, interoperable, reusable).

Theme

  • Show all 2
  • Data protection
  • Ethics
EuroGCT Resource

Data Protection Authorities

  • EU and UK
  • 2023
  • NOVA University of Lisbon, Tilburg University and EuroGCT
Data protection authorities can be categorised into three levels: European Union (EU) level (the European Data Protection Board), National level (the national data protection authorities, designated by the European Union’s General Data Protection Regulation (GDPR) as ‘supervisory authorities’) and Regional level (some countries have regional data protection authorities)

Theme

  • Show all 1
  • Data protection
EuroGCT Resource

Data collection, processing, controlling

  • EU and UK
  • 2023
  • Inserm, University of Toulouse Paul Sabatier and EuroGCT
Health data collection, processing, controlling: as health data reveal sensitive information about the individuals concerned, their use is strictly regulated so as not to infringe the rights and freedoms of the data subjects

Theme

  • Show all 2
  • Data collection, processing, controlling
  • Ethics
EuroGCT Resource

Data Classification

  • EU and UK
  • 2023
  • NOVA University of Lisbon, Tilburg University and EuroGCT
Non personal data, personal data, and more specifically sensitive data such as genetic or health data, as well as electronic health data may be used during the development of gene and cell therapies. Data classification, the nature of the type of data in question, determines the applicable legal norms.

Theme

  • Show all 1
  • Data protection
EuroGCT Resource

Translational Science

  • EU and UK
  • 2023
  • EuroGCT
Translational science translates basic science discoveries into therapeutic applications.

Theme

  • Show all 2
  • Research and Innovation
  • Translational Science
EuroGCT Resource

Conditional Marketing Authorisation of ATMPs

  • EU and UK
  • 2023
  • EuroGCT
To facilitate early patient access to medicinal products, marketing authorisation (MA) can be granted through specific regulatory mechanisms offered by European Union law. When an Advanced Therapy Medicinal Product (ATMP) addresses an unmet medical need of patients, a conditional marketing authorisation may be granted on the basis of less comprehensive data than usually required.

Theme

  • Show all 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Accelerated Assessment of ATMPs

  • EU and UK
  • 2023
  • EuroGCT
To facilitate early patient access to medicinal products, marketing authorisation (MA) can be granted through specific regulatory mechanisms offered by European Union law. The accelerated assessment is a procedural tool to reduce the centralised procedure review period of a marketing authorisation applicant. An applicant may request an accelerated assessment for medicinal products if they are of major public health interest, in particular from the viewpoint of therapeutic innovation.

Theme

  • Show all 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Market Access for ATMPs

  • EU and UK
  • 2023
  • EuroGCT
Market Access for Advanced Therapy Medicinal Products (ATMPs): centralised authorisation procedure, expediting marketing authorisation pathways, and European Medicines Agency (EMA) regulatory support schemes

Theme

  • Show all 1
  • Market access for ATMPs
EuroGCT Resource

Expediting marketing authorisation pathways

  • EU and UK
  • 2023
  • EuroGCT
Within the European Union, three legal procedures have been developed to expedite access to new medicines, including ATMPs: conditional marketing authorisation, marketing authorisation under exceptional circumstances, and accelerated assessment.

Theme

  • Show all 2
  • Commercialisation
  • Market access for ATMPs
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