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Cell and gene therapy products continue to evolve, diversify and challenge the global regulatory frameworks for complex biological medicines. Nevertheless, the industry continues to mature and grow alongside both the skills within the industry and the knowledge of regulatory authorities, with the latter facing ever increasing demands upon their resources. However, in spite of this increase in experience and expertise within the community, and international efforts to increase regulatory harmonization, significant differences in both the legal requirements and scientific guidance for cell and gene therapy products inevitably remain between the major global markets.
The most obvious example of this is between the US and Europe, arguably the two most evolved regulatory frameworks for cell and gene therapy products. This webinar seeks to provide both a high-level overview of the differences between the US and European regulatory requirements for these products and a deeper dive into topics where the disparity between the two territories is greatest. This will include the way that products are classified, the regulation of clinical trials, scientific and regulatory advice procedures, the impact of the EU GMO legislation and product quality (CMC) requirements.
- A greater understanding of key differences between US and EU regulatory requirements and the general approach to cell and gene therapies, including product classification of products, clinical trials, regulatory agency interactions and product designations
- Insights in the environmental aspects of gene therapies (including genetically modified cells), the evolving GMO requirements in Europe including the impact of the new clinical trial regulation, and how these requirements differ from the US
- Insight into the key differences between the US and European manufacturing and donor testing and eligibility requirements for cell and gene therapy products