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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 6 Track 4: Structured Content: Where Are We Now, Where Are We Going, and Practical Applications

Session Chair(s)

Demetra  Macheras, MBA

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)

Stacy  Tegan

Structured Authoring/Structure Content Management – Industry Experience and Lessons Learned

Stacy Tegan

Transcelerate Biopharma, Inc., United States

Program Director

Gary  Saner

Practical Application of Electronic Labeling Adoption in US, Canada, and EU

Gary Saner

Reed Tech, United States

Senior Manager, Information Solutions - Life Sciences

David   Wilson

Speaker

David Wilson

IQVIA Technologies , United States

Associate Director, Regulatory Technology Sales

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