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On-Demand: Access, Medical Devices, Medical Affairs and HCP, Regulatory Submission
Session Chair(s)
Theresa Ambrose Bush, PhD, RAC
Global Director, Personalized Healthcare/Medical Device Regulatory
Roche Diagnostics, United States
Modern and flexible approaches to regulation of next-generation sequencing based diagnostics
Learning Objective : • Understand how global health authorities can modify and adapt regualtory pathways to fit the needs of modern technologies * Understand specifically how the regualtory frameworks for next generation sequencing fit the technological needs of NGS devices
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