Regulatory Aspects of Gene and Cell Therapy Products: A Global Perspective
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Provides a comprehensive overview of the regulatory landscape for gene and cell therapy products globally. Covers key regulatory considerations, including product characterization, clinical trial design, and manufacturing. Examines the role of regulatory agencies in ensuring the safety and efficacy of these products. Discusses the challenges and opportunities in harmonizing regulatory approaches across different jurisdictions. * Offers practical guidance for companies and researchers navigating the regulatory landscape for gene and cell therapy products.
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