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 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
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