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Session 8 Track 1: Incorporating Optimization Strategies for Managing the Processes Associated with End-to-End Labeling Operations and Drug/Device Combination Product Management
Session Chair(s)
Jake Doran
Head of Digital
Lykos Therapeutics, United States
In this session, we will hear from subject matter experts from both industry and service providers and identify and learn about best practices for optimizing the labeling operations capabilities across the life sciences industry. At the heart of the process is the need to have well defined strategies around the data necessary to ensure compliant processes. In addition to labeling, we will explore strategies for managing drug/device combination product regulatory information and how the regulations and requirements associated with these unique products, differ from medical devices or pharmaceutical processes and procedures.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify optimization strategies for managing labeling operations within life sciences
- Understand how broader Regulatory data impacts the end to end Labeling Operations process>/li>
- Understand managing drug/device combination data requirements and learn tips to incorporate best practices
Speaker(s)
Impact of RIM Submission Data Quality on the E2E Labeling Process
Wanda Rosado
Bristol Myers-Squibb, United States
E2E Labeling Process Lead
Effective Labeling Management Requires a New Mindset - A Strategic Guide to Labeling Process Optimization
Cham Williams, MS
IQVIA Technologies, United States
Associate Director, Safety, Regulatory and Quality Customer Engagement
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