Follow-up of patients administered with gene therapy medicinal products - Scientific guideline
HumanAdvanced therapiesScientific guidelines
This document addresses specific aspects of the active clinical follow-up of patients administered with gene therapy medicinal products in order to detect signals of early or delayed adverse reactions, to prevent clinical consequences of such reactions, to ensure timely treatment and to gain information on the long-term safety and efficacy of the intervention.
Keywords: Gene therapy medicinal product, follow-up, risk, adverse events, viral vectors, non-viral vectors, plasmid, genetically modified cell, long-term safety, long-term efficacy