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Session 3: Ensuring Excellence in Safety Labeling: Strategies, Collaboration, and Global Best Practices
Session Chair(s)
Kelly Treonze, MS
Head, Global Labeling Strategy
Merck & Co., Inc., United States
Hayley Parker, PhD, MSc
Senior Vice President
Pepgen Inc., United States
This session will focus on ensuring excellence in safety labeling, including strategies, collaboration and global best practices. Key topics include developing safety text for the CCDS, while balancing the need for to maintain global alignment with region-specific regulatory requirements and managing deviations. Emphasis will be placed on effective collaboration with cross-functional stakeholders (e.g., safety, commercial) through defined roles and responsibilities. The session will also feature case studies to showcase safety labeling practices across therapeutic areas and drug categories.