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DIA Annual Meeting 2024

DIA Annual Meeting 2024
Sessions by Certara:

Certara Innovation Theater: Technology-Enabled Writing – Use CoAuthor™ as your Fully Integrated GenAI Medical Writing Platform

Dr. Christopher Bouton, Senior Vice President and Head of A.I
Demetrius Carter, Senior Vice President, Regulatory Services

CoAuthor™ is the ultimate solution for fast-tracking drug development timelines and improving efficiency in the content generation process. Our AI-powered authoring platform combines the capabilities of Structured Content Authoring and Generative Artificial Intelligence to automate repetitive tasks and streamline the content generation process. With CoAuthor, writers can integrate data directly into documents, ensuring consistency and traceability while using a GenAI assistant to accelerate content generation from complex data inputs. The latest enhancements include the ability to create custom document templates and the application of style guides, providing a seamless integrated experience using MS Word. CoAuthor is the ultimate companion tool that can help you achieve your goals with ease and confidence. Trust in CoAuthor to improve your document quality, increase efficiency, and adhere to industry best practices and lean authoring techniques.

#225: Regulatory Guidance and Papers on Technology Innovations

Session Chair: David Meats, Director, Regulatory Services Management, Certara

Session Speakers:

AI and Technology Trends and Regulation Introduction
David Meats, Director, Regulatory Services Management, Certara

Regulation Guidance and Concensus Papers
Madhavi Gidh-Jain, PhD, Global Medical Writing and Document Management Head, Sanofi, United States

Regulation Guidance
Louise Lind Skov, PhD, Head of Content Digitalisation, Novo Nordisk A/S, Denmark

Demos by Certara

CoAuthor: The Generative AI-Enabled Regulatory Writing Platform

Today’s regulatory writing technology needs to get smarter, while remaining user-friendly and collaborative. With CoAuthor, it has. CoAuthor expedites the writing process by bringing three capabilities into the Microsoft Word UI: fast template selection, structured content authoring, and generative AI.

  • Spend 50% less time formatting your document by applying your style guides to more than 275 eCTD compliant templates.
  • Reuse any portion of your writing, from a compound name to complete paragraphs on mechanism of action, across all your documents.
  • Leverage a biomedically-specialized GPT behind your firewall, for secure, prompt-based text generation


GlobalSubmit eCTD Platform

GlobalSubmit enables teams to manage the regulatory process so they can successfully publish, validate, and review eCTD submissions across a global footprint of regulatory health authorities.

  • Create submissions that conform to any or all of 9 health authorities’ required structure, XML, and validation report.
  • Review eCTD submissions across stakeholders prior to submitting