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Session 8 Track 2A: Interstellar: Crossing the Galaxy between Pharma and Medical Devices/Companion Diagnostics
Learning Objective :
At the conclusion of this session, participants should be able to:
- Compare device classifications
- Discuss regulatory documents associated with medical devices and companion diagnostics
- Organize the associated subject matter within a medical device or companion diagnostics submission
Speaker(s)
IVD Companion Diagnostics – A “Sirius”ly Bright Star
Cyndi Carr, PhD
Ventana Medical Systems, Inc. A Member of the Roche Group, United States
Senior Manager, Medical Writing
Device Classification and Investigational Device Exemptions - Following the Laws of the Universe
Ryan Thomas Hietpas
Eli Lilly and Company, United States
Consultant, Global Scientific Communications
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