On October 17, 2023, Boyds’ regulatory professionals, Dr Patrick Ginty, Senior Director, Regulatory Affairs and Dr Sabine Rühle, Director, Regulatory Affairs will be guest speakers on a webinar hosted by American Association of Pharmaceutical Scientists.

The Webinar, “Highlighting US and European Regulatory Requirements for Gene and Cell Therapy Products”, will 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.

Learning Objectives:

• 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

The webinar will take place on Tuesday, October 17, 2023 a 10:00am EDT. To register for the free webinar, click here.