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Session 9: Risk Management in Digital Combination Product Development and Lifecycle Management
Session Chair(s)
Chin-Wei Soo, DRSC
Global Regulatory Head, PTR Devices and Combination Products
Genentech, A Member of the Roche Group, United States
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
Risk management is an integral part of the development and lifecycle management of digital combination products. An effective deployment of an end-to-end risk management not only meets the regulatory requirements, it ensures the safety of the products. This session will provide the audience with the regulatory basis for implementing risk management and examples of risk management approaches in the pre-market and post-market settings. Risk management associated with cybersecurity will also be discussed.
Learning Objective : - Describe the regulatory basis for implementing risk management
- Apply risk management best practices throughout the lifecycle of digital combination products
Speaker(s)
Speaker
Emily Luvison
Genentech, United States
Principal Lead Cybersecurity Compliance for Digital Health Technologies
Speaker
Matthew Gloss, JD, MBA
Belletorus Corporation, United States
Co-Founder, Chief Operations Officer
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