Regulatory Submissions, Information, and Document Management Forum

戻る Agenda

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