3-day Virtual Seminar

AI for Regulatory Affairs Teams

Overview

Rather than teaching regulatory affairs itself, this webinar focuses on the AI layer being added to regulatory work. It considers the types of language, information and productivity tasks where generative AI may provide useful support, together with the limits that should shape its use.

The session moves from opportunity to control. Participants will consider how AI can assist with organising information, creating working drafts, summarising appropriate material, preparing questions, comparing text and supporting internal communication. From there, the focus turns to the safeguards needed around those activities - reliable sources, output checking, confidentiality, human expertise, governance and escalation when the task carries greater regulatory significance.

Examples are explained within the presentation so attendees can understand the approaches without requiring live access to ChatGPT or another external platform.

Why you should Attend

Regulatory affairs professionals cannot afford to confuse a convincing AI response with an authoritative one. Generative AI may omit important context, rely on outdated knowledge, misunderstand a request or create information that sounds credible but is wrong.

Avoiding AI altogether may mean missing useful efficiency gains; using it without boundaries creates a different set of risks. This webinar explores the middle ground: how regulatory teams can benefit from AI for suitable tasks while retaining source verification, confidentiality, human review and clear accountability for the work that ultimately matters.

Areas Covered in the Session

• Recognise appropriate ways generative AI can support regulatory affairs teams without substituting for regulatory expertise or formal decision-making
  
• Explore uses such as summarising appropriate material, organising information, creating working drafts and supporting internal regulatory communication
  
• Understand how AI can assist with comparing text, extracting key points and preparing structured questions for further review
  
• Strengthen prompting by defining the regulatory context, task boundaries, source expectations and required format more clearly
  
• Spot common AI weaknesses including hallucinations, outdated knowledge, missing nuance and overconfident answers
  
• Apply verification habits that bring AI-generated information back to authoritative guidance, approved source material and professional review
  
• Consider confidentiality, sensitive information and data-handling boundaries when using generative AI for regulatory work
  
• Understand why the risk and level of oversight should increase when AI use could influence higher-impact regulatory activities
  
• Develop a balanced approach to AI adoption based on appropriate use, governance, human accountability and ongoing critical judgement
  

Who Will Benefit

• Regulatory Affairs Managers and Specialists
  
• Regulatory Strategy Professionals
  
• Regulatory Operations Teams
  
• Regulatory Submission and Documentation Professionals
  
• Quality and Compliance Professionals working alongside Regulatory Affairs
  
• Clinical and Product Development Professionals who collaborate with regulatory teams
  
• Life Sciences Project Managers
  
• Managers responsible for AI adoption in regulated functions