Regulatory and Safety Aspects of Cell and 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.
- Guidelines of cell therapy
- safety precautions
Related Conference of Regulatory and Safety Aspects of Cell and Gene Therapy
November 17-18, 2025
18th International Conference on Human Genomics and Genomic Medicine
Paris, France
March 09-10, 2026
21th World Congress on Tissue Engineering Regenerative Medicine and Stem Cell Research
Singapore City, Singapore
June 18-19, 2026
16th International Conference on Human Genetics and Genetic Diseases
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Regulatory and Safety Aspects of Cell and Gene Therapy Conference Speakers
Recommended Sessions
- Advanced Gene Therapeutics
- Bioengineering Therapeutics
- Cell and Gene Therapy for Rare & Common Diseases
- Cell Culture and Bioprocessing
- Cell Science and stem cell research
- Cell Therapy
- Cell Therapy for Cardiovascular and Neurological Disorders
- Clinical Trials on Cell & Gene Therapy
- Ethical Issues in Cell and Gene Therapy
- Gene Therapy
- Genetics & Genomic Medicine
- Genome Editing
- Markets & Future Prospects for Cell & Gene Therapy
- Molecular Basis of Epigenetics
- Nano Therapy
- Regulatory and Safety Aspects of Cell and Gene Therapy
- Stem Cell Research
- Stem Cell Therapies
- Tissue Engineering & Regenerative Medicine
- Viral Gene Therapy
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