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
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9/12/2019 8:00:00 AM9/12/2019 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
