概要
This course provides a structured introduction to companion diagnostics, focusing on the terminology, regulatory frameworks, and global requirements that guide their development and use. Participants will examine key US and EU regulations and guidances, understand IVD classifications, and review the expectations for clinical studies and commercial IVD products. By the end of the course, learners will be able to apply foundational knowledge to ensure the compliant and effective development of companion diagnostics in alignment with international standards.