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Sponsored Presentation

Sponsored Presentations - Round 2: Evaluation & Qualification of Novel Technologies in Medicinal Products' Clinical Trials: Another Field of Interaction Between Medtech and Pharma Sectors

Thursday, May 7, 2026
10:15 - 10:40 WEST
Location: Exhibition Hall - Spark!

Sponsored By: 
Description Innovations in medical device and In vitro diagnostics devices opens new application opportunities in the field of pharma R&D. Non genomics or biological biomarkers could be defined from digital measures. Those processes are different from both MDR/IVDR conformity assessment or FDA MD/IVD market clearance procedures. Some criteria as the "context of use" are specifics. A good understanding of this procedure is essential for a streamlined application process.

Learning Objectives:

  • Develop knowledge about digital biomarkers and novel technologies assessment for pharmaceutical products development.
  • Comparison between US FDA and EMA novel technologies assessment for pharma R&D.
  • Comprehensive presentation of the US and EMA submission processes.