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Session 6 Track 4: Structured Content: Where Are We Now, Where Are We Going, and Practical Applications
Session Chair(s)
Demetra Macheras, MBA
Director, Regulatory Policy and Intelligence - Regulatory Affairs
AbbVie, United States
This session will provide a high-level overview of the benefits, and lessons learned of structured authoring/structured content management implementation through the use of interactive audient polling and feedback from industry interviews. Presenters will discuss the history of structured file formats and the requirements and submission formats in the U.S., Health Canada, and the EU, including:
- U.S. FDA implementation of SPL, XML, and REMS
- Health Canada’s implementation of XML PM and the evolution of the Product Monograph to the 2020 format
- EMA SPOR implementation program and how to take advantage of early timelines
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss the status of the progress of and opportunity provided by implementation of structured authoring/structured content management
- Describe the evolution and current state of US, Health Canada, and EU structured product labeling requirements and submission formats
Speaker(s)
Structured Authoring/Structure Content Management – Industry Experience and Lessons Learned
Stacy Tegan
Transcelerate Biopharma, Inc., United States
Program Director
Practical Application of Electronic Labeling Adoption in US, Canada, and EU
Gary Saner
Reed Tech, United States
Senior Manager, Information Solutions - Life Sciences
Speaker
David Wilson
IQVIA Technologies , United States
Associate Director, Regulatory Technology Sales