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Session 10 Track 3: CTD Structured Authoring and the Shift Away from Documents
Session Chair(s)
Joanne Malia, MS, MSc
Director, Development Records Management
Regeneron Pharmaceuticals, United States
This session will discuss the paradigm shift which is needed in this industry to move away from documents to a data focus. The presenters will discuss the advantages and challenges with structured authoring and ways to provide this to business applications. Participants will be encouraged to engage into the discussion regarding the paradigm shift coming to our industry.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the paradigm shift and the advantages and challenges that come with it
- Understand structured content authoring (SCA) and its terminology
- Recognize how and where to use SCA within your business application scope
Speaker(s)
Increasing Efficiencies Through Data Reuse in CTD Modules with Structured Content Authoring integrated in Veeva
Manuela Bernhardt, MS
Fme US, LLC, United States
Business Unit Director - Technology Services
Shifting Focus from Document to Component Management: A New Regulatory Paradigm
Donald Palmer, MA
United States
Consultant