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

March 15-15, 2021

Genetics and Molecular biology

Paris, France
September 27-28, 2021

15th International Conference on Genomics & Pharmacogenomics

Vancouver, Canada
December 07-08, 2021

2nd World Congress on Cell and Structural Biology

Sydney, Australia
December 09-10, 2021

2nd International Conference on Geriatrics and Ageing

Sydney, Australia

Regulatory and Safety Aspects of Cell and Gene Therapy Conference Speakers

Recommended Sessions

Related Journals

Are you interested in