Global Pharmaceutical Regulatory Affairs Summit: Structured Content and Integrated Data

Today, Jan Benedictus presented at the Global Pharmaceutical Regulatory Affairs Summit 2022 in Berlin: “The Future of Documents: Structured Content, Integrated Data”.

Global Pharmaceutical Regulatory Affairs Summit

The Global Pharmaceutical Regulatory Affairs Summit focuses on the challenges of IDMP, RIM, eSubmissions and Global Market Regulation in the pharmaceutical industry.

GPRAS 2022 in Berlin

The Future of Documents

The Future of Documents is shaped by a fundamental change in how information is shared. This future sees a shift from traditional ‘e-paper’, formatted and optimized for reading by humans, towards semantically tagged information in an open digital format.

  • Define Structured Content. What is it and why is it so fundamentally different from formatted documents?
  • What are the essential parts of a content architecture, and why is it important?
  • Use cases: Labeling, Clinical, Regulatory, Reporting
  • Operational aspects: how can writers be engaged and turned into enthusiasts.
  • What can we learn from industries where structured content authoring is common practice?

Structured content authoring in regulated industries

There is a lot of opportunity for structured content authoring in regulated industries, like pharma and life sciences. Last year, Manuela Bernhardt (fme) already mentioned: “We see the increasing need and urgency to find structured document solutions within different processes of our Life Sciences clients”. And also Val Swisher (Content Rules) mentioned this: “Highly regulated industries such as finance and life sciences, should be the next target for structured content”.

The Future of Documents: Structured Content, Integrated Data

Download the full presentation slide deck, as presented by Jan Benedictus on GPRAS in Berlin. Feel free to contact us in case you have questions regarding this presentation or if you want to have a demo of Fonto Editor in combination with pharma specific configurations.

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