Web resource for basic and clinical research in Gene Therapy, cell therapy, and genetic vaccines. In addition, it provides an overview of the different international regulations and guidelines associated with clinical Gene Therapy trials.
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This NCATS-led pilot project will test whether it is possible to increase the efficiency of Gene Therapy clinical trial startup by using the same Gene Delivery System and manufacturing methods for multiple gene therapies.
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Quality, preclinical and clinical aspects of Gene Therapy medicinal products
Published by EMA
Quality GuidelineGene TherapyAdvanced TherapyRegulatory AffairsATMPNon-ClinicalGuide for the development and evaluation of Gene Therapy Medicinal Products (GTMPs) intended for use in humans and presented for Marketing Authorisation Application (MAA). Its focus is on the quality, Safety and efficacy requirements of GTMPs.
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Guideline On The Non-Clinical Studies Required Before First Clinical Use Of Gene Therapy Medicinal Products
Published by EMA
Regulatory AffairsEarly Access SupportAdvanced TherapyGene TherapyNon-ClinicalFirst Clinical UseThis document defines scientific principles and provides guidance to applicants developing Gene Therapy medicinal products (GTMPs). It focuses on the non-clinical studies required before the first use of a GTMPs in human subjects.
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Guideline On Development And Manufacture Of Lentiviral Vectors
Published by EMA
Early Access SupportAdvanced TherapyGene TherapyATMPLentiviral VectorRegulatory AffairsThis guideline describes quality aspects that are relevant for lentiviral vectors (LV). It applies to LV intended for ex vivo or in vivo application.
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