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Bethesda North Marriott Hotel and Conference Center

Feb 13, 2023 11:30 AM - Feb 15, 2023 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 2: Is it Time to Streamline Your Processes with Structured Content Management?

Session Chair(s)

Katherine  Novak, MS

Katherine Novak, MS

Principal Consultant

Epista Inc., United States

Structured Content Management (SCM) is once again gaining traction as a technical solution to streamline content authoring and re-use of critical product information. The current standard processes for document management are no longer sufficient for streamlining submissions or able to support the level of content management, collaboration, and re-use that is possible with the transition from documents to data.

This session will focus on practicalities and benefits of SCM, including:

  • The benefits of transitioning from documents to data-centric processes
  • Practical use cases and key success factors for SCM
  • Mindset shifts and organizational readiness
  • Industry case studies in Regulatory and Pharmacovigilance document authoring

Learning Objective :
  • Describe the differences between document-based authoring and component-based authoring to understand the value of managing content at the component level
  • Discuss how the industry uses SCM to streamline their pharmacovigilance and regulatory document authoring and content approval processes
  • Increase understanding of approaches to automating reuse of content
  • Increase understanding of how SCM fits within the larger tech ecosystem

Speaker(s)

Neel  Patel, MS

Digital Transformation Empowered by Structured Content and Collaborative Authoring

Neel Patel, MS

Red Nucleus, United States

Principal Consultant

Jason  Hirschhorn, MBA

Accelerating Submissions Through Data and Content Reuse and Automation (SCM)

Jason Hirschhorn, MBA

Point B, United States

Director

Gary  Colantonio, MBA, MS

Streamlining Pharmacovigilance and Regulatory Document Authoring Using Structured Content Management

Gary Colantonio, MBA, MS

Merck, United States

Assoc. Dir, Regulatory Affairs

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