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Session 7 Track 2: Is it Time to Streamline Your Processes with Structured Content Management?
Session Chair(s)
Katherine Novak, MS
Principal Product Manager
Accumulus Synergy, 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)
Digital Transformation Empowered by Structured Content and Collaborative Authoring
Neel Patel, MS
Red Nucleus, United States
Principal Consultant
Accelerating Submissions Through Data and Content Reuse and Automation (SCM)
Jason Hirschhorn, MBA
Point B, United States
Director
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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