Veristat Resource Library

Expediting Access to Novel/Medicinal Products in the US and EU Replay

What  You Will Learn

 

Bringing novel medicinal products to market is a long, complex, and expensive process which requires drug developers to balance the need for rigorous testing with the goal of getting medicines quickly to patients who need them. To this end, both US and European regulatory agencies have developed expedited pathways to accelerate the approval process for therapies that treat serious conditions and unmet medical needs.  

Veristat Regulatory experts will discuss how developers of such therapies can utilize some or multiple programs/pathways to accelerate approval in the US and Europe. This webcast will highlight the requirements, benefits, and procedures for following US pathways: Accelerated Approval, Breakthrough Therapy Designation, Fast Track, and Priority Review Designation. Then we will examine the similarities and differences to the EU pathways: Accelerated Assessment, Conditional Marketing Application (CMA), and Priority Medicines Scheme (PRIME). The discussion will culminate with real-world examples and success stories. 

 

Our experts will share their experience, successes, and lessons learned on how to:

• Understand when and how to apply for the following expedited pathways with FDA and European Regulatory Authorities:   

1.  Breakthrough Therapy (BT)
2.  Fast Track (FT)
3.  Priority Review
4.  Accelerated Approval 
5.  Accelerated Assessment
6.  Conditional Marketing Authorization (CMA)
7.  PRIME  

•  Consider real-world examples of increased efficiency with submitting pathways requests with FDA and EMA independently and simultaneously 

 

download