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Leveraging Testing Results Generated Within Treating Hospitals for Trials Across the Globe
Session Chair(s)
Mike Wierzba, PHD
Snr. Director, GRA, Precision Medicine and Digital Health, GSK, United States
Precision medicine biomarker testing can be achieved in various formats, harnessing results generated in each patient's treating hospital or in centralized laboratories. We will examine resulting regulatory and technical challenges & opportunities.
Learning Objective : Demonstrate an understanding of different testing models (central vs decentralized); Identify their regulatory consequences for clinical study conduct and approval.
Speaker(s)
Panelist
Senior Vice President of Operations, Discovery Life Sciences Biomarker Services GmbH, Germany
Panelist
Clinical Development Lead (Director), Pathology Lab, Roche Tissue Diagnostics, United States
Panelist
Biologics Quality Assessor, Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
Panelist
Senior Director, Regulatory Affairs, Bayer, United States
Panelist
IVDR Project Manager | Assessment and Surveillance, Health Products Regulatory Authority (HPRA), Ireland
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