From the Integrity of Potency Assays to Safe Clinical Intervention: Legal Perspectives

Author:

Roslin Waltter,Mansnérus Juli

Publisher

Springer International Publishing

Reference24 articles.

1. CAT work plan 2021. Available from https://www.ema.europa.eu/en/documents/other/cat-work-plan-2021_en.pdf. Accessed 28 July 2021

2. CBER/FDA (2011) Guidance for industry potency tests for cellular and cene therapy products

3. Cuende N, Álvarez-Márquez AJ, Díaz-Aunión C, Castro P, Huet J, Pérez-Villares JM (2020) Promoting the ethical use of safe and effective cell-based products: the Andalusian plan on regenerative medicine. Cytotherapy 22:712–717

4. European Commission (2017) Guidelines of 22.11.2017 good manufacturing practice for advanced therapy medicinal products

5. European Medicines Agency (2008) Guideline on Human cell-based medicinal products (EMEA/CHMP/410869/06)

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