Innovative Regulatory Pathways Summit
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.
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.
Top Five Reasons to Attend
- Navigate the expedited drug development options provided by the FDA
- Discuss clinical requirements for breakthrough therapy designation and the impact of receiving designation on trail design/CMC plans
- Utilize patient-focused drug development to build clinical trial frameworks for breakthrough therapy applications
- Discuss regulatory strategies to expedite oncology and rare disease product development timelines
- Compare Sakigake, PRIME, and Breakthrough Therapy Designation to expedited tracks in non-ICH countries
The Innovative Regulatory Pathways Summit speaking faculty includes representatives from GlaxoSmithKline, Friends of Cancer Research, Alexion Pharmaceuticals, Novartis, and other organizations.
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Be sure to use Priority Code: C1010PP when registering