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Regulatory Perspectives and Considerations for Cell & Gene Therapies

October 17, 2016

This whitepaper elaborates the fundamental regulatory concerns associated with the development of cell and gene therapy products, and the need for international harmonization of regulatory requirement for approval of cell and gene therapies.Finally, the paper addresses the urgent unmet need to provide regulatory certainty in the field of cell and gene therapeutics in the fast evolving global regulatory landscape.

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