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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 17
EuroGCT Resource

Condivisione dei dati / Dati aperti

  • 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

  • Mostra tutti 2
  • Data sharing / Open Data
  • Ethics
EuroGCT Resource

Raccolta, elaborazione e controllo dei dati

  • 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

  • Mostra tutti 2
  • Data collection, processing, controlling
  • Ethics
EuroGCT Resource

Autorità di protezione dei dati

  • 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

  • Mostra tutti 1
  • Data protection
EuroGCT Resource

Principi fondamentali della protezione dei dati

  • 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

  • Mostra tutti 2
  • Data protection
  • Ethics
EuroGCT Resource

Classificazione dei dati

  • 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

  • Mostra tutti 1
  • Data protection
EuroGCT Resource

Pubblicità dei MTA

  • 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

  • Mostra tutti 2
  • Commercialisation
  • Advertising
EuroGCT Resource

Autorizzazione all'immissione in commercio condizionata per i medicinali per terapie avanzate

  • 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

  • Mostra tutti 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Dossier della domanda di autorizzazione all'immissione in commercio per gli MTA

  • EU and UK
  • 2022
  • EuroGCT
Marketing authorisation application requires from the applicant the submission of a file containing documentation and data related to the medicinal product to be authorised. The file must comply with the Common Technical Document (CTD), a set of specifications for the marketing authorisation application dossier. Under the centralised procedure the application is submitted under a standardised electronic format, the electronic Common Technical Document (eCTD), through an online portal.

Theme

  • Mostra tutti 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Procedura centralizzata per i medicinali per terapie avanzate

  • EU and UK
  • 2022
  • EuroGCT
The centralised procedure allows an ATMP to be commercialised and made available to patients and healthcare professionals throughout the entire European Union on the basis of a single marketing authorisation at the European level.

Theme

  • Mostra tutti 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Mission creep / Abuso dei dati

  • EU and UK
  • 2023
  • Brunel University London and EuroGCT
Mission creep or data misuse is focused on the legitimacy and purposes for which patient data is collected, used, stored, and processed.

Theme

  • Mostra tutti 2
  • Data
  • Mission creep / data misuse
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