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Medical Affairs and Scientific Communications Forum

Medical Communication, MSL, and Medical Writing.

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
      Cyndi  Carr, PhD

      IVD Companion Diagnostics – A “Sirius”ly Bright Star

      Cyndi Carr, PhD

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

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

      Ryan Thomas Hietpas

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