Regulatory Strategies to Employ When Your Study Doesn’t Qualify for Breakthrough/Prime

September 12, 2019 8:00 AM - 10:00 AM

MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

Add to Calendar 9/12/2019 8:00:00 AM 9/12/2019 10:00:00 AM Regulatory Strategies to Employ When Your Study Doesn’t Qualify for Breakthrough/Prime It is well understood that achieving Breakthrough or Prime Designation status provides sponsors with significant advantages in the regulatory process to achieve approval. However – not every drug candidate will qualify. This Forum will showcase best practice and real world examples of regulatory success, even without achieving coveted breakthrough status.
  • Overview of Breakthrough vs Fast Track vs Accelerated Approval, etc.
  • FDA and EMA engagement techniques to keep momentum and enthusiasm even without Breakthrough
  • Panel will share success stories and real-world examples of their strategies and FDA / EMA interactions that allowed for regulatory success
  • Equally important – what NOT TO DO examples will be shared
 MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

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