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.

 

 

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