Exploring Non-Invasive Biomarkers from a Regulatory Perspective to Understand What Features the FDA/EMA Assess When Approving Biomarkers in the Context of NASH Drug Development

Time: 10:00 am
day: Post Conference Seminar Day


• Explaining the ‘Biomarker Qualification Program’ in depth
• Understanding the analytical considerations of the program
• Deep diving into NASH biomarker considerations from an FDA perspective