Back to Agenda
Session 4 - From Labeling (Global and Local) Through Dossier Content Using XML - Extending the Value of Structured Content Management and Reuse
Session Chair(s)
Gerrit Nijveldt, MSc
Global Labeling Consultant
Opus Regulatory Inc., United States
This session will discuss opportunities to how XML and DITA (Darwin Information Typing Architecture ) are being used to link and reuse content from the CCDS to local labels and to link to parts of dossier. Use of XML is not new for labeling and eCTD, this is a new way of working to extend use of XML/DITA to link the CCDS (or local labeling text) directly into the supporting documents, for example, the clinical documents. The XML/DITA tool has been implemented in use in clinical documentation, narratives, protocols, biostatistics, SAP and global labeling. This will be discussed from labeling point of view but also from XML and DITA expert point of view describing opportunities and solutions.
Speaker(s)
Introduction
Gerrit Nijveldt, MSc
Opus Regulatory Inc., United States
Global Labeling Consultant
XML/DITA Tool
Ole Rom Andersen
DITA Exchange, United States
Director / Co-founder
XML/DITA Tool
Derek VanRheenen
Amgen Inc., United States
Principal Business Analyst
Use of XML/DITA from a Company Perspective
Mitzi Allred, PhD
Merck & Co., Inc, United States
Director, Clinical Operations
Have an account?