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Regulatory submissions still are very much centered around “classic” documents: formatted PDFs. The common practice is still to write in Microsoft Word and copy and paste data manually. This intrinsically poses risk of inconsistencies; the inefficiency of the practice is increasingly problematic.

While documents are accompanied by structured XML for key-data and meta-data, documents and data are still “separate worlds.” Structured content has the potential to bridge them. Structured documents are component-based, contain included data and are largely created automatically. 

Companies are starting to roll-out structured content authoring management and authoring for various use-cases. In this talk, we shared successes and lessons from projects where we are involved:
  • Content architecture definition: what does it mean, and why is it important?
  • Components and reuse, how to find the best level of granularity.
  • Content as data: how is semantic tagging different from formatting?  
  • New ways of writing: how to engage writers and turn them into enthusiasts.


Speakers:

Cham Williams

Associate Director, Business Systems

IQVIA


Cham Williams has more than 20 years’ experience in the life sciences industry working globally for pharmaceutical, consulting and technology solutions companies. His expertise includes managing regulatory technology, business process optimization and systems planning and implementation. As a principal consultant, Cham advised clients on regulatory strategy and process development. He started his career as part of a pioneering submissions team recognized for submitting electronic CRFs, which later led to the development of electronic NDAs.  Now at IQVIA, Cham is bridging the technology and business worlds, designing products that help shape the next generation of RIM solutions. Cham holds a BS in Economics from the University of the West Indies and a MS in Project Management from Drexel University.

Julian Backhouse

Associate Director, Regulatory Technology

IQVIA


Julian Backhouse is an Associate Director – Regulatory Technology, leading the team responsible for labelling solutions at IQVIA. He has over 25 years of experience in component content management, automation and global change control. Leveraging insights from CPG, FMCG and Life Science, within which he specializes in labelling and packaging artwork management, localization and automation, he has held positions in product strategy, technology delivery and consulting services.

Donald Palmer

Senior Regulatory Affairs Director, Business & Technology Transformation

IQVIA


As the Senior Regulatory Affairs Director for Business & Technology Transformation, Donald works with the Global Regulatory Affairs (GRA) team at IQVIA to add and update technology solutions to GRA's business processes. His experience bridges the business and technology divide that spans Regulatory submissions, document management, and Regulatory Information Management, especially as they integrate with other departments and systems.  Having worked in several organizations of different sizes, he provides perspectives from sponsors, vendors and now CROs.  He is a strong proponent of standards and data governance. With a BA and MA in Mathematics, Donald became fully involved in the pharmaceutical industry just as electronic submissions were starting late in the 1990’s and has over 20 years’ experience in the industry.

Jan Benedictus

CEO

Fonto


Jan Benedictus is Founder and CEO of Fonto. His experience goes back to the late 1990's when he started working in the field of online and digital publishing. In 2014, he started Fonto - with the mission to make structured content authoring available for everyone.
Today, Jan heads the company behind the leading user-friendly tools for structured content creation, editing and review; Fonto.  He is a regular speaker on the subject of The Future of Documents; sharing Fonto's experiences and insight from working with structured content in Pharma and across other industries.

Jason Berning

Associate Business Development Director Regulatory Technology Solutions

IQVIA


Jason Berning has more than 10 years of experience in Regulatory Technologies in various roles that include: consulting, product management, and sales. As an Associate Dir. of Business Development at IQVIA Jason focuses on bringing transformational Regulatory Technology and Consulting solutions to his customers. He has worked with a wide variety of pharma companies of various sizes and is passionately optimistic about the digitalization of regulatory affairs.


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