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Cell Manufacturing l Part 4
Navigating the Regulatory Environment: International Regulations for Pluripotent Derived Products
The manufacturing and commercialization of a cellular therapy has numerous challenges, including navigating the complex international jurisdictions and regulations of such products. While efforts to harmonize many of these standards are underway, the current regulatory landscape varies by country and jurisdiction so advance understanding of the relevant standards and regulations is important if one wants to develop a product that is marketed in different regions of the world. In this program you will hear from experts who have gone through this process from the development and regulatory perspectives.
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