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Session 8 Track 3: The Evolution of Documents to Digital – New Solutions Using Emerging Technologies
Session Chair(s)
Karen McCarthy Schau
Director, Risk-based Study Management
Vertex Pharmaceuticals, United States
Pharma and biotech companies share three critical business goals: scalability, getting safe and effective drugs to market faster, and reducing risk. To achieve these goals, we need to reduce the time it takes to create, manage, and publish content. This is an interactive session where leaders in protocol digitalization and analytics will discuss their experience in the context of potential use cases and the required foundational work needed. In addition, the session will explore a digital solution which allows anyone in the organization to perform contextual searches of global dossiers on file with a Health Authority and provide the unique opportunity to drill down to specific details within each dossier.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand how digital tools can unlock true value of regulatory dossiers
- Understand the key data needed to extract from historical protocol documents to enable you to achieve your analytic objectives
- Describe the next steps one can take on their journey to structured content
Speaker(s)
Component-Based Structured Content Management: The Pharma Content Evolution
Regina Lynn Preciado
Content Rules, Inc., United States
Senior Director of Content Strategy Solutions
Digital Protocols – The Foundation for Achieving Your Clinical Design Objectives through AI and Predictive Analytics
Will Bryant, MBA
Point B Consulting, United States
Principal
eCTD Viewing Analytics Case Study: Generating Actionable Insights from Global Dossier Submission Data
Jason Mattis, MBA, MSc
Johnson & Johnson, United States
Director, Regulatory Affairs CMC
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