21^st Global Biomarkers and Clinical Research Summit

Regulatory Considerations for Biomarker Validation

The validation of biomarkers is critical for their successful integration into clinical practice, and regulatory considerations play a significant role in this process. This session will explore the current landscape of biomarker regulation, including guidelines from regulatory agencies such as the FDA and EMA.

Presenters will discuss best practices for biomarker validation, including the importance of robust clinical studies and data integrity. Challenges related to regulatory pathways and the need for collaboration between researchers and regulatory bodies will also be addressed, providing attendees with practical insights for navigating the regulatory environment.