3-day Virtual Seminar

AI for Health Authority Responses

Overview

This session follows the health authority response process from question to final review and considers where generative AI may assist along the way. Participants will explore how AI can help break down complex questions, organise contributing information, summarise appropriate source material, support the structure of working drafts and compare sections for consistency.

The webinar also examines the points where caution becomes critical. AI should not invent evidence, determine regulatory strategy or replace the specialists responsible for the underlying scientific, clinical, quality or regulatory content. Attendees will consider how to verify outputs, maintain alignment with authoritative source material, protect sensitive information and use clear review controls before AI-assisted content moves forward.

Examples are explained within the presentation so participants can understand the approach without requiring live access to external AI tools.

Why you should Attend

Health authority questions often arrive under time pressure, and AI can appear to offer a shortcut. The risk is that an AI-generated response may be fluent but incomplete, introduce unsupported statements, miss the intent of the authority’s question or create inconsistencies with information already submitted.

This webinar shows how AI can be used more carefully as a support tool around the response process. Attendees will learn where it may help with organisation, drafting and review, while understanding why source evidence, cross-functional input, verification and final human accountability remain essential.

Areas Covered in the Session

• Break down health authority questions into clear issues, information needs and response components before using AI
  
• Identify appropriate ways AI can support information organisation, summarisation and preparation of internal working drafts
  
• Use structured prompts to define the authority question, available source material, boundaries and required response format more clearly
  
• Explore how AI can assist with comparing draft content against source information and identifying potential inconsistencies for review
  
• Recognise unsupported statements, hallucinations, missing context and overconfident language that can undermine an AI-assisted response
  
• Keep scientific, clinical, quality and regulatory subject-matter experts responsible for the evidence and conclusions within the response
  
• Apply source verification, cross-functional review and human approval before AI-assisted wording is incorporated into formal regulatory work
  
• Consider confidentiality, data handling, document control and governance when using generative AI during response preparation
  
• Use a proportionate approach in which the level of AI reliance and review reflects the significance and potential regulatory impact of the task
  

Who Will Benefit

• Regulatory Affairs Managers and Specialists
  
• Regulatory Strategy Professionals
  
• Regulatory Operations Teams
  
• Submission and Response Management Professionals
  
• Quality and CMC Professionals contributing to authority responses
  
• Clinical and Safety Professionals supporting regulatory questions
  
• Medical and Regulatory Writers
  
• Cross-Functional Project Teams involved in agency interactions
  
• Managers responsible for AI adoption within regulated functions