On-Demand Webinar: Expediting Access to Novel/Medicinal Products
Expediting Access to Novel/Medicinal Products in the US and EU | Regulatory Pathways to Speed Development and Approval
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.