Perspectiva general

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.

Temas destacados

Basics of companion diagnostics
Overview of US and EU regulations
Relevant US and EU guidances
US and EU requirements for the conduct of clinical studies
US and EU requirements for commercial IVD products

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This course is designed for professionals involved in:

Objetivos de aprendizaje

At the conclusion of this course, participants should be able to:

Define key terms related to companion diagnostics.
Identify global guidances and regulations impacting the development of companion diagnostics.
Differentiate IVD classifications.
Recognize global requirements for the conduct of clinical studies in companion diagnostics.
Outline requirements for commercial IVD products.

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Developing Companion Diagnostics: Regulatory and Clinical Considerations in the US and EU

Perspectiva general

Temas destacados

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Objetivos de aprendizaje

Be informed and stay engaged.