Meet MARIE: Writing the Dossier with your Scientific Virtual Companion

Discover how MARIE, a Scientific Virtual Companion, transforms structured enterprise data into submission-ready documents. See how data-driven templates and AI-generated narrative work together to create consistent, traceable first drafts for expert review, from CMC content to regulatory response documents.

What participants will learn

See the end-to-end authoring workflow, including:

• Templated content assembly that brings approved components together efficiently.
• Data-driven documents where parameters trigger queries to automatically populate tables and other data elements.
• AI-assisted authoring with MARIE, generating narrative in your organization’s established voice and style.
• Manual and AI-assisted authoring, showing how human expertise and AI can work together.
• Prompt-enabled templates, where embedded prompts execute after data retrieval to generate context-aware narrative automatically.

You’ll leave with a clear understanding of how data-driven templates and AI-assisted authoring can produce high-quality, consistent first drafts while keeping experts in control of review and approval.

Who Should Attend?

• Regulatory Affairs Specialists & Authors looking to reduce authoring timelines and eliminate manual copy & paste work.
• CMC & Quality Assurance Leads seeking to automate CMC dossier & APQR preparation while improving alignment between scientific and manufacturing data.
• Technical Writers interested in leveraging structured data templates and AI-assisted authoring.
• R&D Informatics & IT Directors evaluating solutions to connect scientific data with downstream regulatory content & publishing.