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Regulatory Submissions, Information, and Document Management Forum

Session 6 Track 2: Structured Content Management

Session Chair(s)

Michiel  Stam

Michiel Stam

  • Head of Data Management and Regulatory Information Scientist
  • Qdossier, Netherlands
Maintaining information on product characteristics for marketed and development drugs across all countries is a complex and laborious task. Content is often duplicated, difficult to retrieve and reviewed and approved multiple times, resulting in a waste of time and resources. Managing this contents and associated processes in a structured way offers many great advantages, including increased efficiency, transparency, improved quality of information, and better decision making. This session will focus on several business cases for structured contents management and the importance of standardized or structured processes, utilizing structured data.
Learning Objective : 1. See how DOCX looks like in XML 2. See how DOCX can contain tagged information with tags corresponding to IDMP 3. Understand how RIMs can be used for populating DOCX files 4. Learn how the current Module 3 document templates are impacted 5. Understand how electronic application forms could ease our lives in maintaining compliance.


Jack  Yeager

Structured Information and Process Management Reduce Drug Development by $250 Million

Jack Yeager

  • CEO
  • Sylogent, United States
Hans  van Bruggen, MSc

DOCX; Ability to Channel Regulatory Information from Company Databases Through Documents to Agency Databases

Hans van Bruggen, MSc

  • CEO and Senior RA Consultant
  • Qdossier, Netherlands
Mark  Cottingham

A Grand Design

Mark Cottingham

  • Sr. Business Lead in Operational Business Excellence Group of Pharma Technical
  • F. Hoffmann-La Roche Ltd, Switzerland