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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

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

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


Wanda  Rosado

Impact of RIM Submission Data Quality on the E2E Labeling Process

Wanda Rosado

Bristol Myers-Squibb, United States

E2E Labeling Process Lead

Cham  Williams, MS

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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