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Preclinical Testing Issues Developing Combinations Products – Drug or Device Pathway?

February 21, 2019 @ 11:00 am - 12:00 pm

Approximately one-third of all medical products developed today are combination products. These devices require a unique approach when applying for regulatory approval.

In this hour-long webinar, Michael Dellogono, Ph.D., will discuss how to select the correct testing pathway and what regulatory requirements your device must meet – helping you reduce the time and stress involved with developing a preclinical testing program.

During this presentation he will review:

  • Is your product a Drug or Device in the eyes of regulatory agencies?
  • The blending of the biocompatibility & pharmaceutical pathways
  • An overview of the biocompatibility requirements for combination devices
  • The array of safety toxicology studies needed for all the materials in your product

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February 21, 2019
11:00 am - 12:00 pm
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