Halloran Speaker Series: Navigating the Complexities of Expedited Product Approval Pathways

Description

Global health authorities have long recognized the need to facilitate development and minimize delays in patient access for novel treatments intended for serious and life-threatening disease. Over the past decade, FDA, EMA and PMDA have launched various “expedited programs” to foster collaboration with industry in the delivery of these promising new therapies. This speaker series will discuss the nature of these expedited programs, the corresponding benefits for qualifying products and learnings from real-world experience. 

Key topics will include: 

• A comparison of expedited programs in US, EU and Japan with a focus on US offerings. Which programs make the most sense for my \ product(s)? 
• New pilot programs introduced by FDA. How do these new initiatives relate to the existing offerings? Should we participate? 
• Case studies from various expedited programs with a focus on the impact to CMC product development. 

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