3-day Virtual Seminar

AI for eCTD Submission Preparation

Overview

This webinar examines how generative AI can support the work surrounding eCTD submission preparation without confusing AI assistance with technical publishing or regulatory validation. The session looks at content-heavy activities where AI may be useful, such as organising source information, creating working summaries, improving clarity, comparing related text and preparing internal checklists or questions for review.

Participants will also consider the limitations that matter in electronic submissions. FDA specifications and supported eCTD versions change over time, AI knowledge may be outdated, generated content may introduce inconsistencies, and confidential regulatory information requires careful handling. The session therefore places source verification, version awareness, document control, human review and use of approved publishing and validation processes alongside any potential efficiency gains.

Examples are presented within the webinar and do not require live access to eCTD publishing software or external AI platforms.

Why you should Attend

An eCTD submission can contain thousands of pages of interconnected information, and small inconsistencies or preparation errors can create avoidable rework. AI may help teams work through content more efficiently, but an AI-generated answer cannot confirm that a submission meets FDA’s current technical specifications or validation criteria.

This webinar helps attendees separate useful AI assistance from false confidence. It explores where generative AI may support preparation and review activities while keeping current FDA standards, approved publishing processes, specialist review and formal validation as the final authority.

Areas Covered in the Session

• Understand the current FDA eCTD landscape, including the coexistence of supported eCTD v3.2.2 and v4.0 standards
  
• Identify content-preparation and information-management tasks where generative AI may provide useful support before formal publishing
  
• Explore AI-assisted approaches to summarising source material, organising information, comparing related content and preparing internal working checklists
  
• Use prompts that clearly define the document context, source material, intended purpose and limits of the requested output
  
• Recognise hallucinations, outdated technical information and inconsistencies that can arise when AI is used around regulatory submission content
  
• Verify AI-assisted information against current FDA guidance, technical conformance materials, submission standards and authoritative source documents
  
• Consider confidentiality, proprietary information, document control and appropriate handling of submission content when using AI tools
  
• Distinguish AI-supported content preparation from eCTD publishing, technical validation and regulatory decisions that require approved systems and specialist expertise
  
• Build a controlled workflow in which AI may support preparation while regulatory professionals, publishing processes and formal validation remain responsible for submission readiness
  

Who Will Benefit

• Regulatory Affairs Professionals
  
• Regulatory Operations Professionals
  
• eCTD Submission and Publishing Teams
  
• Regulatory Submission Managers
  
• Medical and Regulatory Writers
  
• Document Management and Submission Support Professionals
  
• Quality and Compliance Professionals supporting regulatory submissions
  
• Regulatory Project Managers
  
• Managers responsible for AI adoption within regulatory operations