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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 87
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

Advertising of ATMPs

  • EU and UK
  • 2023
  • EuroGCT
Advertising of medicinal products, including ATMPs, is mainly regulated by National laws apart from minimum binding requirements established by EU Law.

Theme

  • Show all 2
  • Commercialisation
  • Advertising
EuroGCT Resource

Commercialisation

  • EU and UK
  • 2022
  • EuroGCT
Enabling timely patient access to Advanced Therapy Medicinal Products (ATMPs), commercialisation covers marketing authorisation, and post-authorisation activities such as pharmacovigilance, pricing and reimbursement.

Theme

  • Show all 6
  • Commercialisation
  • Market access for ATMPs
  • Distribution
  • Advertising
  • Pharmacovigilance
  • Pricing & reimbursement
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

Marketing Authorisation under exceptional circumstances for 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. A marketing authorisation under exceptional circumstances for medicinal products may be granted when the applicant is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because the indication to be treated is too rare, the present state of scientific knowledge is insufficient to provide comprehensive information, or it would be unethical to collect this information.

Theme

  • Show all 2
  • Commercialisation
  • Market access for ATMPs
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