Subramanya Prasad Peri

As interest in intranasal therapeutics accelerates, spanning systemic delivery, local nasal treatments, and emerging nose-to-brain approaches, regulatory expectations have become increasingly complex and highly product-specific. Intranasal drugs no longer follow a single pathway, mechanism of action, target tissue, or delivery method.

This has shaped what evidence regulators require. Designed for teams developing and bringing intranasal products to market, this hands-on workshop, led by senior regulatory experts with direct experience navigating FDA and EMA submissions, will cut through the complexity by blending case examples with practical frameworks. Participants will gain clarity on how to design development programs that are compliant, efficient, and

approval ready.

This workshop will explore:

• Regulatory Expectations Across Modalities: Understand what FDA and EMA require for intranasal drugs, and where the grey areas lie
• Designing Evidence Packages that Accelerate Approval: Learn how to strategically plan compatibility studies, human factors assessments, PK/PD work, and device performance data to support smoother submissions
• Avoiding Common Pitfalls in Nasal Drug Development: Explore real-world missteps in formulation, device selection, safety data, and early study design that slow development, and learn how to proactively mitigate them