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Poster de conférence Année : 2023

Finding out the regulatory requirements for the development of Gene and Cell therapy products with the EuroGCT research pathways

Résumé

1. Background Communicating information on the regulatory framework applicable to gene and cell therapies, at every stage of development and towards every actor involved, is a challenge. Therapy development needs to comply with several regulatory requirements mostly to ensure products’ and patients’ safety, the complexity comes from the diversity of the regulatory frameworks. Some requirements are binding, others are guidance only. Most aspects are governed by European Union law, but some remain regulated on a national scale. The regulatory landscape is a combination of general and specific rules and guidance depending on competent institutions (e.g. EU and Member States regulatory agencies or health technology assessment bodies), types of products, and steps of their developments. 2. Methods The European Consortium for Communicating Gene and Cell Therapy Information (EuroGCT) is building an online tool to provide research pathways’ information. Therefore, communicating clear, precise, and accurate information in the form of a database. It will allow professionals of the field as well as patients to be informed on all regulatory aspects of the development of a Gene and Cell therapy product. 3. Results Depending on the legal classification of these therapies different regulatory pathways appear, which are shown on the EuroGCT website. Becoming a “one-stop shop” for accurate legal information on the legal classification of Gene and Cell therapies from lab to patient. 4. Conclusions The tool will facilitate better decision-making at key points in development of new therapies and thus enable improved product development, by providing the research community and regulatory and healthcare authorities with an information source on the practical steps needed for cell and gene therapy development.
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Dates et versions

halshs-04290303, version 1 (16-11-2023)

Identifiants

  • HAL Id : halshs-04290303 , version 1

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Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo, Jennifer Lorigan, Clare Blackburn, et al.. Finding out the regulatory requirements for the development of Gene and Cell therapy products with the EuroGCT research pathways. European Society for Blood and Marrow Transplant 49th annual meeting, Apr 2023, Paris, France. ⟨halshs-04290303⟩
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Dernière date de mise à jour le 28/04/2024
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