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Omni Rancho Las Palmas Resort & Spa

19 mar 2018 1:00 p.m. - 21 mar 2018 4:00 p.m.

41000 Bob Hope Drive, Rancho Mirage, CA 92270

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

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

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

Ryan Thomas Hietpas

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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