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In this webinar, industry leaders discuss regulatory requirements for GMP ancillary materials and the importance of regulatory documentation and support to enable successful clinical translation of cell and gene therapies. Also discussed are key considerations for commercialization such as scalability, consistency of supply and commercial use rights.
Topics covered:
- Regulatory requirements for GMP ancillary materials for cell and gene therapy
- Regulatory documentation and vendor support for successful clinical translation
- Commercial-use considerations for late-phase clinical trials and commercial manufacturing