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Leveraging Testing Results Generated Within Treating Hospitals for Trials Across the Globe
Session Chair(s)
Mike Wierzba, PhD
Director, GRA, Precision Medicine and Digital Health
GlaxoSmithKline, 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
Oliver Stoss, PhD
Discovery Life Sciences Biomarker Services GmbH, Germany
Senior Vice President of Operations
Panelist
Amanda Baker, PharmD, PhD
Roche Tissue Diagnostics, United States
Clinical Development Lead (Director), Pathology Lab
Panelist
Ilona Reischl, PhD, MPharm
Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
Biologics Quality Assessor
Panelist
Adriana Racolta, PhD, RAC
Pfizer Inc, United States
Director, Regulatory Affairs, Companion Diagnostics
Panelist
Philip Kelly, PhD
Health Products Regulatory Authority (HPRA), Ireland
IVDR Project Manager | Assessment and Surveillance
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