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Session 10B1: Some of my Best Friends are Devices - An Introduction to the Regulations and Documents of Medical Devices and In Vitro Diagnostics
Session Chair(s)
Robin Whitsell
President
Whitsell Innovations, Inc., United States
Did you know most device submissions are still paper or hybrid? Did you know that a device can be awarded “clearance” or “approval”? Have you ever tried to coordinate a pharmaceutical submission with its companion diagnostic or worked with your team/company to determine how they define a drug/device combo? This session will introduce the differences in writing and regulation for medical devices and diagnostics. The speakers will share their experiences in the documentation, timeline development, and processes for this form of regulatory writing. They will also discuss how medical devices and diagnostic writing differs from pharmaceutical regulatory writing.
Learning Objective : At the conclusion of this session, participants should be able to:- Interpret an overview of submission requirements for diagnostics and diagnostics
- Identify key documentation associated with devices and diagnostics
- Discuss the regulatory implications associated with these submissions
Speaker(s)
Speaker
Robin Whitsell
Whitsell Innovations, Inc., United States
President
Speaker
Cathi Harmon
Eli Lilly and Company, United States
Manager, Global Scientific Communications
Speaker
Hal J Mann, MBA
Roche Molecular Solutions, Inc., United States
Director, Clinical Operations, Trial Support and Strategic Outsourcing