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Updated: Jul 28, 2025

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

Waltter Roslin1, Juli Mansnérus2

  • 1University of Helsinki, Helsinki, Finland.

Advances in Experimental Medicine and Biology
|May 31, 2023
PubMed

Keywords:
ATMP regulationAllogeneic or autologousClinical trialsClinical trials directiveEU guidance documentsEU regulatory frameworkHospital exemptionLegalMarketing authorizationRegulatory landscape

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