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Latest in Combination Product Industry Trends: Development and Submission Strategies for Success
Session Chair(s)
Rumi Raquel Young, MS
Director, Regulatory Policy
Novo Nordisk A/S, United States
Explore the latest combination product trends, sustainability in design, recent FDA/global guidelines, post-approval device changes, and emerging submission practices to help navigate the evolving regulatory landscape and achieve development success.
Learning Objective : Discuss recent FDA and global guidelines (ICH Q1, ICH Q6, ICH M4Q) to inform effective control strategies & stability programs; Recognize how to manage post-approval changes for device constituents and focusing on best practices; State recent submission trends (e.g., Human Factors) and successful health authority interactions to accelerate development.
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