Gene Therapy Assays: Achieving Regulatory Compliance With A Unified Immunogenicity Strategy

Delve into the intricacies of designing immunogenicity assays that comply with both European IVDR and US FDA regulations. This presentation aims to provide actionable insights, focusing on the challenges and strategies for seamlessly integrating these regulatory requirements into clinical trial plans. By ensuring that your assays are both effective and compliant, the discussion will offer valuable guidance on navigating the complex landscape of regulatory demands.

Expert speakers provide a deeper understanding of assay customization, learning how targeted design can significantly streamline the path to regulatory approval. The webinar also addresses the complexities of integrating regulatory demands into clinical trials, offering practical solutions and strategies to optimize assay effectiveness across multiple regions. Whether you are struggling with the intricacies of regulatory compliance or seeking ways to enhance the efficiency of your assays, this session promises to equip you with the knowledge and tools needed to stay ahead in the field.