Illuminating Immunohistochemistry: Right-Sizing Your Validation And Regulatory Strategy

This session will provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC), offering crucial insights into the regulatory landscape and validation processes necessary for successful clinical trials.

Our expert speakers, Kennon Daniels, PhD, a scientific and regulatory authority in in vitro diagnostics from Precision for Medicine, and Christie Bongel, MS, CT(ASCP), an experienced site director specializing in cytology and molecular diagnostics at Precision for Medicine, will guide you through the complexities of regulatory requirements. They will ensure that your IHC assays are compliant and optimized for clinical use.

During this session, you will gain a comprehensive understanding of foundational laws and standards that govern IHC validation. The speakers will discuss how to align your validation and regulatory strategies with the goals of US clinical trials, ensuring that your assays meet all necessary criteria. Additionally, the session will cover the regulatory differences between the US and Europe, providing a comparative analysis that highlights key differences and implications for your IHC assays.

By attending this session, you will be equipped with the knowledge and tools needed to navigate the complexities of regulatory compliance and validation, ultimately ensuring the success of your clinical trials. This is an invaluable opportunity to learn from industry experts and enhance your understanding of IHC regulatory strategies.