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
February 20-21, 2023
13th International Conference and Exhibition on Advanced Cell and Gene Therapy
Madrid, Spain
April 12-13, 2023
18th World Congress on Tissue Engineering Regenerative Medicine and Stem Cell Research
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13th International Conference on Human Genetics and Genetic Diseases
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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
- Cell Therapy in Pulmonology:
- Cellular therapy
- Clinical trials in cell and gene therapy
- Diabetes Gene Therapy
- Gene therapy
- Gene Therapy Commercialization
- Genomics
- HIV gene therapy
- Regulatory & Safety Aspects of Cell & Gene Therapy
- Skin cell therapy
- Vectors for Gene Therapy
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