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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) that inform effective control strategies & stability programs; Recognize how to manage post-approval changes for device constituents and focusing on best practices; State recent IND and submission trends (e.g., Human Factors, design verification, stability) and successful health authority interactions to accelerate therapies to patients.
Speaker(s)
Panelist
Representative Invited
FDA, United States
Panelist
Katie Duncan, PHD
GSK, United States
Director, CMC Policy and Advocacy
Panelist
Chelsea O'Connell, MS, RAC
Amgen, United States
Director, Global Regulatory Policy & Intelligence
Panelist
Alan Stevens, MS
AbbVie, United States
Global Head, Complex Devices and Drug Delivery Systems
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