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
September 12-13, 2024
14th International Conference and Exhibition on Advanced Cell and Gene Therapy
Rome, Italy
September 26-27, 2024
19th World Congress on Tissue Engineering Regenerative Medicine and Stem Cell Research
Amsterdam, Netherlands
November 21-22, 2024
17th International Conference on Human Genomics and Genomic Medicine
Dubai, UAE
February 24-25, 2025
19th International Conference on Regenerative Repair and Medicine
Madrid, Spain
April 03-04, 2025
15th International Conference on Human Genetics and Genetic Diseases
Madrid, Spain
April 29-30, 2025
3rd International Conference on Cell Science and Molecular Biology
Barcelona, Spain
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
Related Journals
Are you interested in
- Advanced Gene Therapeutics - WORLD CELL THERAPY 2025 (France)
- Artificial Intelligence and Machine Learning in Regenerative Medicine - REGENERATIVE MED MEET 2025 (Spain)
- Bio Banking Stem cell - STEM CELL CONGRESS 2024 (France)
- Biochemical Genetics: - Human Genetics 2025 (Spain)
- Bioengineering Approaches in Regenerative Medicine - REGENERATIVE MED MEET 2025 (Spain)
- Bioethics and Genomic Research - HUMAN GENOME 2024 (UAE)
- Bioinformatics - HUMAN GENOME 2024 (UAE)
- Bioinformatics and Systems Biology - cellscience-cs-2025 (Spain)
- Bioinformatics in Cell and Gene Therapy - Cell Therapy 2024 (Italy)
- Bioinformatics, Machine learning and Statistical methods - HUMAN GENETICS MEET 2024 (France)
- Bone Marrow Transplantation - STEM CELL CONGRESS 2024 (France)
- Bone Marrow Transplantation - WORLD CELL THERAPY 2025 (France)
- Cancer Biology and Cell Signaling - cellscience-cs-2025 (Spain)
- Cancer Genetics: - Human Genetics 2025 (Spain)
- Cancer Genomics - HUMAN GENOME 2024 (UAE)
- Cancer, Cardiovascular Diseases and Genetics - HUMAN GENETICS MEET 2024 (France)
- CAR-T Cell Therapy: Current Status and Future Directions - Cell Therapy 2024 (Italy)
- Cardiovascular Regeneration - REGENERATIVE MED MEET 2025 (Spain)
- Cell and Genetic Therapy - STEM CELL CONGRESS 2024 (France)
- Cell and Genetic Therapy - WORLD CELL THERAPY 2025 (France)
- Cell and Tissue Engineering - cellscience-cs-2025 (Spain)
- Cell Biology and Therapy - WORLD CELL THERAPY 2025 (France)
- Cell Culture and Bioprocessing - WORLD CELL THERAPY 2025 (France)
- Cell Cycle and Cell Division - cellscience-cs-2025 (Spain)
- Cell Migration and Invasion - cellscience-cs-2025 (Spain)
- Cell Therapy for Cardiovascular Diseases - Cell Therapy 2024 (Italy)
- Cell-Based Therapies for Neurological Disorders - Cell Therapy 2024 (Italy)
- Cellular Mechanotransduction - cellscience-cs-2025 (Spain)
- Cellular Metabolism and Metabolic Disorders - cellscience-cs-2025 (Spain)
- Cellular Reprogramming and Induced Pluripotent Stem Cells - Cell Therapy 2024 (Italy)
- Cellular Therapies - WORLD CELL THERAPY 2025 (France)
- Clinical Genetics and Novel Therapies of Genetic Diseases - HUMAN GENETICS MEET 2024 (France)
- Clinical Genetics: - Human Genetics 2025 (Spain)
- Clinical Methods - STEM CELL CONGRESS 2024 (France)
- Clinical Trials and Research in Cell and Gene Therapies - WORLD CELL THERAPY 2025 (France)
- Clinical Trials in Cell and Gene Therapy - Cell Therapy 2024 (Italy)
- Cognitive Computing - HUMAN GENOME 2024 (UAE)
- Computational Biology - HUMAN GENOME 2024 (UAE)
- CRISPR and Genome Editing Technologies - cellscience-cs-2025 (Spain)
- Cytogenetics: - Human Genetics 2025 (Spain)
- Dental and Craniofacial Regeneration - REGENERATIVE MED MEET 2025 (Spain)
- Dental Stem Cells - STEM CELL CONGRESS 2024 (France)
- Developmental Biology and Regenerative Medicine - cellscience-cs-2025 (Spain)
- Developmental Genetics: - Human Genetics 2025 (Spain)
- Drug Delivery Strategies for Gene Therapies - Cell Therapy 2024 (Italy)
- Drug Detection & Development in Bioinformatics - HUMAN GENOME 2024 (UAE)
- Drug Detection & Development in Bioinformatics - WORLD CELL THERAPY 2025 (France)
- Education and Training in Genomic Medicine - HUMAN GENOME 2024 (UAE)
- Emergency Genomic Medicine - HUMAN GENOME 2024 (UAE)
- Environmental Applications of Regenerative Techniques - REGENERATIVE MED MEET 2025 (Spain)
- Epigenetics - Human Genetics 2025 (Spain)
- Epigenetics and Epigenomics - cellscience-cs-2025 (Spain)
- Epigenetics and Gene Regulation - HUMAN GENETICS MEET 2024 (France)
- Epigenetics Biomarkers - HUMAN GENOME 2024 (UAE)
- Ethical & Social Implications of Gene Editing: - Human Genetics 2025 (Spain)
- Ethical and Regulatory Issues in Regenerative Medicine - REGENERATIVE MED MEET 2025 (Spain)
- Ethical Considerations in Genome Editing - Cell Therapy 2024 (Italy)
- Evolutionary and Population Genetics - HUMAN GENETICS MEET 2024 (France)
- Functional Genomics and Transcriptomics - HUMAN GENETICS MEET 2024 (France)
- Gene Cloning and Mapping - HUMAN GENETICS MEET 2024 (France)
- Gene Editing and CRISPR Technologies - REGENERATIVE MED MEET 2025 (Spain)
- Gene Editing and Technologies - WORLD CELL THERAPY 2025 (France)
- Gene Editing Technologies: CRISPR and Beyond - Cell Therapy 2024 (Italy)
- Gene Therapy - Human Genetics 2025 (Spain)
- Gene Therapy and Genetic Counseling: - Human Genetics 2025 (Spain)
- Gene Therapy for Ophthalmic Diseases - Cell Therapy 2024 (Italy)
- Genes and Immunology - HUMAN GENOME 2024 (UAE)
- Genes and Immunology - WORLD CELL THERAPY 2025 (France)
- Genetic Counseling: - Human Genetics 2025 (Spain)
- Genetic Disorders - Human Genetics 2025 (Spain)
- Genetically Modified Organisms - HUMAN GENOME 2024 (UAE)
- Genome Mapping - HUMAN GENOME 2024 (UAE)
- Genomic Approach to Drug Discovery - HUMAN GENOME 2024 (UAE)
- Genomic Medicine - HUMAN GENOME 2024 (UAE)
- Genomic Medicine & Molecular Diagnostics: - Human Genetics 2025 (Spain)
- Genomic Technologies in Forensic Science - HUMAN GENOME 2024 (UAE)
- Genomic Vaccination - HUMAN GENOME 2024 (UAE)
- Genomics: - Human Genetics 2025 (Spain)
- Human Gene Therapy - HUMAN GENOME 2024 (UAE)
- Human Gene Therapy - WORLD CELL THERAPY 2025 (France)
- Human Genetic Engineering: - Human Genetics 2025 (Spain)
- Human Genetics - HUMAN GENETICS MEET 2024 (France)
- Human genetics - Human Genetics 2025 (Spain)
- Human Genetics and Genomics - HUMAN GENOME 2024 (UAE)
- Immunogenetics: - Human Genetics 2025 (Spain)
- Immunomodulation and Inflammation in Regeneration - REGENERATIVE MED MEET 2025 (Spain)
- Immunotherapy and Regenerative Medicine - REGENERATIVE MED MEET 2025 (Spain)
- Immunotherapy and Regenerative Medicine - WORLD CELL THERAPY 2025 (France)
- Immunotherapy in Cancer Treatment - Cell Therapy 2024 (Italy)
- Infectious Diseases - HUMAN GENOME 2024 (UAE)
- Manufacturing Challenges and Solutions in Cell and Gene Therapy - Cell Therapy 2024 (Italy)
- Medical Genetics - Human Genetics 2025 (Spain)
- Microbiome and Host Interactions - cellscience-cs-2025 (Spain)
- Molecular and Cellular Immunology - cellscience-cs-2025 (Spain)
- Molecular and Cytogenetics - HUMAN GENETICS MEET 2024 (France)
- Molecular and Cytogenetics - WORLD CELL THERAPY 2025 (France)
- Molecular Effects of Genetic Variation - HUMAN GENETICS MEET 2024 (France)
- Molecular Genetics - Human Genetics 2025 (Spain)
- Molecular Genetics and Gene Therapy - cellscience-cs-2025 (Spain)
- Molecular Pathology and Diagnostics - cellscience-cs-2025 (Spain)
- Molecular Phenotyping and Omics Technologies - HUMAN GENETICS MEET 2024 (France)
- Musculoskeletal Regeneration - REGENERATIVE MED MEET 2025 (Spain)
- Mutation Detection and Analysis - HUMAN GENETICS MEET 2024 (France)
- Mutation Detection and Analysis - WORLD CELL THERAPY 2025 (France)
- Nanotechnology in Cell Biology - cellscience-cs-2025 (Spain)
- Nanotechnology in Stem Cell - WORLD CELL THERAPY 2025 (France)
- Neurobiology and Neurodegenerative Diseases - cellscience-cs-2025 (Spain)
- Neurodegenerative Disease - STEM CELL CONGRESS 2024 (France)
- Neuroregeneration - REGENERATIVE MED MEET 2025 (Spain)
- Nutritional Genomics: - Human Genetics 2025 (Spain)
- Oncogenomics and Cancer Heredity: - Human Genetics 2025 (Spain)
- Organ Regeneration and Bio Artificial Organs - REGENERATIVE MED MEET 2025 (Spain)
- Patient Advocacy and Engagement in Clinical Trials - Cell Therapy 2024 (Italy)
- Pharma Genomics & Pharma Informatics - HUMAN GENOME 2024 (UAE)
- Pharmacogenetics: - Human Genetics 2025 (Spain)
- Pharmacogenomics - HUMAN GENETICS MEET 2024 (France)
- Population Genetics: - Human Genetics 2025 (Spain)
- Preimplantation Genetic Diagnosis (PGD) - HUMAN GENOME 2024 (UAE)
- Proteomics and Protein Engineering - cellscience-cs-2025 (Spain)
- Public Health Implications of Gene Editing - Cell Therapy 2024 (Italy)
- Recent Advances in Stem Cell Research - Cell Therapy 2024 (Italy)
- Regenerative Approaches in Cancer Therapy - REGENERATIVE MED MEET 2025 (Spain)
- Regenerative Medicine and Tissue Engineering - Cell Therapy 2024 (Italy)
- Regenerative Medicine in Space Exploration - REGENERATIVE MED MEET 2025 (Spain)
- Regenerative Medicine in Veterinary Care - REGENERATIVE MED MEET 2025 (Spain)
- Regenerative Strategies for Aging and Longevity - REGENERATIVE MED MEET 2025 (Spain)
- Regulatory Landscape for Cell and Gene Therapies - Cell Therapy 2024 (Italy)
- Respiratory and Pulmonary Regeneration - REGENERATIVE MED MEET 2025 (Spain)
- Sickle cell Anaemia Genomics - HUMAN GENETICS MEET 2024 (France)
- Signal Transduction and Cell - cellscience-cs-2025 (Spain)
- Single-Cell Analysis and Applications - cellscience-cs-2025 (Spain)
- Stem Cell & Regenerative Drugs - STEM CELL CONGRESS 2024 (France)
- Stem Cell Animal Applications - STEM CELL CONGRESS 2024 (France)
- Stem Cell Apoptosis - STEM CELL CONGRESS 2024 (France)
- Stem Cell Biology and Therapy - REGENERATIVE MED MEET 2025 (Spain)
- Stem Cell Embryology - STEM CELL CONGRESS 2024 (France)
- Stem Cell in Cardiovascular Disease - STEM CELL CONGRESS 2024 (France)
- Stem Cell in Drug Development - WORLD CELL THERAPY 2025 (France)
- Stem Cell Research and Therapy - cellscience-cs-2025 (Spain)
- Stem Cell Research and Therapy: - Human Genetics 2025 (Spain)
- Stem Cell Research: - Human Genetics 2025 (Spain)
- Stem Cell Therapy - STEM CELL CONGRESS 2024 (France)
- Stem cell Therapy: - Human Genetics 2025 (Spain)
- Stem cell Transplantation - HUMAN GENETICS MEET 2024 (France)
- Stem Cells and Disease Modelling - STEM CELL CONGRESS 2024 (France)
- Stem Cells in Drug Discovery - STEM CELL CONGRESS 2024 (France)
- Structural Biology and Molecular Dynamics - cellscience-cs-2025 (Spain)
- Synthetic Biology and Bioengineering - cellscience-cs-2025 (Spain)
- The Evolution of Cell and Gene Therapy - Cell Therapy 2024 (Italy)
- Tissue Engineering - STEM CELL CONGRESS 2024 (France)
- Tissue Engineering and Biomaterials - REGENERATIVE MED MEET 2025 (Spain)
- Tissue Engineering and Biomaterials - WORLD CELL THERAPY 2025 (France)
- Translational Medicine - HUMAN GENETICS MEET 2024 (France)
- Translational Research and Clinical Trials - REGENERATIVE MED MEET 2025 (Spain)
- Translational Research and Clinical Trials - WORLD CELL THERAPY 2025 (France)
- Translational Research in Stem Cell - STEM CELL CONGRESS 2024 (France)
- Vector Development for Gene Therapy - Cell Therapy 2024 (Italy)
- Viral Gene Therapy - WORLD CELL THERAPY 2025 (France)