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Omni Rancho Las Palmas Resort & Spa

Mar 19, 2018 1:00 PM - Mar 21, 2018 4:00 PM

41000 Bob Hope Drive, Rancho Mirage, CA 92270

Medical Affairs and Scientific Communications Forum

Medical Communication, MSL, and Medical Writing.

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Session 8 Track 2A: Interstellar: Crossing the Galaxy between Pharma and Medical Devices/Companion Diagnostics

Session Chair(s)

Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc., United States

Pharmaceuticals and biologics are more frequently innovating through the use of novel devices and companion diagnostics to accurately identify the best option for patients. Pharmaceutical professionals and regulatory agencies are in need of proficiency in the language and documentation associated with medical devices and companion diagnostics. This session will provide an overview of the regulations surrounding medical devices and companion diagnostics, steps for bringing medical devices to the market, and practical knowledge in writing the associated documents. The speakers will introduce these regulations in the context of similar pharmaceutical regulations. They will detail the required documentation associated with Pre-Market Approval (PMA) and Pre-Market Notification (510(k)s) for medical devices and companion diagnostics. The speakers will also provide an overview of investigational device exemptions (IDE) and a case-study of an IDE filing.

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)

Cyndi Carr, PHD

Senior Manager, Medical Writing, Ventana Medical Systems, Inc. A Member of the Roche Group, United States

IVD Companion Diagnostics – A “Sirius”ly Bright Star

Ryan Thomas Hietpas

Ryan Thomas Hietpas

Consultant, Global Scientific Communications, Eli Lilly and Company, United States

Device Classification and Investigational Device Exemptions - Following the Laws of the Universe

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