Regulatory & Safety Aspects of Cell & Gene Therapy
Cell therapy products require a variety of safety considerations. Stem cell and gene products are heterogeneous substances. There are several areas that particularly need to be addressed as it is quite different from that of pharmaceuticals. These range from creating batch consistency, product stability to product safety, strength and efficacy through pre-clinical, clinical studies and marketing authorization. This review summarizes the existing regulations/guidelines in US, EU, India, and the associated challenges in developing SCBP with emphasis on clinical aspect.
Related Conference of Regulatory & Safety Aspects of Cell & Gene Therapy
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Regulatory & Safety Aspects of Cell & Gene Therapy Conference Speakers
Recommended Sessions
- Genetically inherited diseases
- Viral gene therapy
- Advanced gene therapy
- Cancer gene therapy
- Cancer Gene Therapy
- Cell & Gene Therapy Products
- Cell and Gene therapy products
- Cell Culture & Bioprocessing
- Cell Science & Stem Cell Research
- Cell Therapy
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- Cellular therapy
- Clinical trials in cell and gene therapy
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