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Short Course* Registration: 12:00-4:30PM

*Lunch is not included in Short Course registration.

The short course will explore a series of case studies of complex combination products legal and regulatory issues. This will cover areas such as digital health, primary modes of action, drug delivery systems, biologic-device issues, and complex generics. This will dynamic and interactive course will allow you the chance to engage with the instructors and your peers to assess and analyze the regulatory challenges posed in both hypothetical and real-life case studies.

*Short Courses are not included in the conference registration and require a separate fee.

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Learning objectives

At the conclusion of this short course, participants should be able to:

  • Describe the more complex combination products issues arising at FDA
  • Evaluate the FDA's position on complex combination products regulatory issues
  • Apply concepts learned to resolve challenges in the work setting with complex combination products

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