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Session 8: Connected Combination Products
Session Chair(s)
David Amor
Digital Health - QA/RA
Apple, United States
With the advent of digital health upon us, combination product manufacturers have been working hard to integrate “connected” capabilities to their products. From talking auto-injectors to dose-counting inhalers, combination products with a digital health component will continue to empower providers and patients by providing data and actionable insights. This session will review regulatory and quality considerations for connected combination products while reviewing several case studies and examples.
Learning Objective : At the conclusion of this session, participants should be able to:- Explain the regulatory path considerations for connected combination products
- Build a “Design History File” for a connected combination product
- Answer what an appropriate Quality Management System looks like for a connected combination product manufacturer
Speaker(s)
Connected Combination Products
Tina Murphy, PhD
Novartis Pharmaceuticals Corporation, United States
Global Program Regulatory Director, Regulatory Affairs Innovation