Loading Events

« All Events

  • This event has passed.

R&Q Webinar: Wait, what? That’s a combination product?

September 25, 2018 @ 1:00 pm - 2:00 pm

Join BioOhio member R&Q for a webinar on September 25 at 1pm.

Is there a medical device hiding in your product portfolio?

Combination products – defined in 21 CFR 3.2(e) – are often stealthy, and once you’ve discovered one, do you know what to do? This webinar will answer those questions and more. After defining what constitutes a combination product and examining other vital basics, we’ll share numerous case studies that shed light on how other companies of different sizes have assessed their product portfolios, discovered combination products, and acted accordingly.

What’s Covered:

  • What is – and isn’t – a combination product
  • Development risks and how to avoid them
  • Importance of a regulatory strategy
  • Primary mode of action (POMA) and other considerations
  • Device vs. drug quality systems
  • Post-market considerations
  • Managing “design creep”
  • Instrumental case studies demonstrating what to do

Key Takeaways:

  • Know exactly what constitutes a combination product
  • Learn essential information surrounding combination products
  • Understand how a combination product(s) affects your regulatory and quality processes
  • Know immediate actions and next steps once identifying a combination product(s) in your portfolio
  • Valuable insight from experienced industry leaders