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ExL Innovative Regulatory Pathways Summit
January 29 - January 30
There are regulatory mechanisms in place to accelerate the review and/ or approval of treatments for patients. In the United States, Accelerated Approval, Breakthrough Therapy Designations, Fast Track Designation, Priority Review, and the Orphan Drug Act are designed to expedite treatment availability for medications that provide an increased benefit over existing treatments.
Breakthrough therapy designations and other expedited pathways encourage sponsors to increase communication and collaboration with the FDA, to enable efficient drug development. Accelerated drug development options are also available globally in ICH countries through programs like PRIME and Sakigake. Understanding how to best utilize these regulatory options is imperative to make an informed decision about the best ways to accelerate drug development.
ExL’s Innovative Regulatory Pathways Summit will bring together leading regulatory experts and thought leaders to discuss breakthrough therapy designations, accelerated approvals, and global regulatory strategies to expedite review/approval of drugs that have promise in treating serious or life-threatening conditions.