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Harnessing the Power of Structured Content in Life Sciences: Practicalities, Challenges, and Opportunities in the Evolving Technology Landscape


Overview

As the Regulatory and Clinical Operations industry progresses toward digitalization, the idea of “Structured Content Authoring” or “Structured Component Management” is once again gaining traction as a tool to increase efficiency and quality of day-to-day operations. Although this is not a new concept, technological advancement and a move towards data-centric processes make this a reality.

This session will examine the current technology landscape for structured content solutions in life sciences and hear directly from panelists on their experiences with structured content within their organizations. The panel session will focus primarily on:

  • Use cases in Regulatory and Clinical Operations
  • Success Stories
  • Challenges and the Importance of Organization Change Management
  • The Future of Structured Content

Please also check out DIA’s Regulatory Submission, Information, and Document Management Forum taking place February 13-15 in Bethesda, MD!


Meeting Designed For

  • Regulatory Affairs and Operations
  • Regulatory Information Management
  • Regulatory Informatics
  • Submissions and Global Submissions Management/Project Management
  • Medical, Technical, and Regulatory Writers
  • TMF and eTMF Management
  • Informatics/Bioinformatics Professionals
  • Document and Records Management/Specialists
  • Essential Document Process and Business System Owners
  • Regulatory Standards Implementation Specialists and Associates
  • Clinical Operations and Processes
  • Quality Management
  • Quality Assurance/Quality Control and Compliance Professionals
  • Strategic Planning and Operations
  • Contract Research and Service Support Providers
  • Emerging Pharmaceutical/Biotech/Device Professionals
  • Outsourcing/Clinical Outsourcing
  • Vendor Relationship Managers

Learning objectives

At the conclusion of this session, participants should be able to:
  • Summarize the current technology landscape for structured content solutions as applicable to life sciences
  • Identify opportunities for improvement, utilizing structured content, in their organization’s current processes
  • Discuss the practicalities and key success factors for structured content processes in Regulatory and Clinical Operations