AI in Regulatory Affairs: Uses, Risks and FDA Guidance
Date: April 24, 2026
Duration: 60 Minutes
Time: 12 PM EST
AI in Regulatory Affairs: Practical Uses, Hallucination Risks and FDA’s Emerging Guidance on AI-Assisted Submissions
Artificial intelligence is no longer a distant promise in the life sciences – it is actively reshaping how regulatory submissions are written, reviewed, and managed. From automating literature searches and drafting Common Technical Document (CTD) narratives to flagging inconsistencies across thousands of pages of clinical data, AI tools like ChatGPT, Gemini, Claude, Grok, Copilot, and purpose-built regulatory platforms are already on the desks of regulatory affairs professionals across the industry.
But with this rapid adoption comes a critical question: Are we using these tools safely and compliantly? FDA has begun signaling its expectations around AI-generated content in submissions, and the agency’s scrutiny is growing. Hallucinated citations, fabricated regulatory precedents, and inconsistent data summaries are not hypothetical risks – they are documented failure points that can delay approvals, trigger information requests, or worse, result in patient safety issues.
This 60-minute webinar cuts through the hype to deliver practical, experience-backed guidance on how to harness AI in regulatory affairs responsibly, what the FDA is looking for, and how to build internal guardrails that protect your submissions – and your organization.
Topics to Be Covered
The State of AI in Regulatory Affairs Today
An honest assessment of where AI tools are being used across the drug development and regulatory submission lifecycle — from IND preparation to NDA/BLA compilation – and where industry adoption currently stands.
Practical AI Use Cases That Deliver Real Value
- Automating gap analysis in Module 2 summaries and clinical overviews
- AI-assisted literature review for safety updates and DSURs
- Using large language models to draft and cross-check labeling language
- Accelerating responses to FDA Information Requests (IRs) and deficiency letters
- AI-powered eCTD assembly and publishing quality checks
The Hallucination Problem: Real Risks in a High-Stakes Environment
AI models can confidently produce inaccurate regulatory citations, nonexistent FDA guidances, or subtly misrepresented clinical data. We will examine documented examples from regulatory submissions and explore why hallucinations are particularly dangerous in a heavily scrutinized, compliance-driven environment.
FDA’s Emerging Position on AI-Assisted Submissions
A deep dive into FDA’s recent discussion papers, draft guidances, and public statements related to AI in drug development. We will cover what the agency has signaled about AI-generated content, transparency expectations, and how reviewers are being trained to identify AI-assisted submissions.
Building an AI Governance Framework for Regulatory Functions
- Establishing validation and verification protocols for AI-generated content
- Defining human-in-the-loop review standards for submission documents
- Documentation and audit trail requirements for AI-assisted workflows
- Training your team to critically evaluate AI outputs before they go to FDA
Vendor Evaluation: Questions You Must Ask Before Deploying Regulatory AI Tools
Not all AI platforms are created equal. Learn the critical due diligence questions to ask vendors about data security, model training, hallucination mitigation, and regulatory validation before you sign a contract.
Live Q&A with the Presenter
An open, interactive session where attendees can bring their own organizational challenges, edge cases, and questions about AI in their specific regulatory contexts.
Why Should You Attend?
AI adoption in regulatory affairs is accelerating faster than guidance can keep up. Professionals who understand both the opportunity and the risk will be positioned to lead their organizations through this transition confidently. Attendees of this webinar will walk away with:
- A clear-eyed understanding of where AI genuinely adds value and where it creates unacceptable risk in regulatory submissions
- Concrete frameworks for governing AI use within their regulatory affairs teams, ready to adapt to their organization’s risk appetite
- First-hand insight into FDA’s evolving expectations, drawn from 20 years of frontline regulatory experience and active engagement with agency reviewers
- Practical tools to evaluate and audit AI-generated regulatory content before it reaches the agency
- Confidence to have informed conversations with leadership, IT, legal, and vendors about responsible AI deployment in a regulated environment
Whether your organization has already deployed AI tools or is still evaluating options, this session will give you the regulatory intelligence to move forward without putting your submissions or your patients at risk.
Who Will Benefit?
This webinar is designed for mid-to-senior level professionals operating at the intersection of science, compliance, and regulatory strategy. You will find this session especially relevant if you work in any of the following roles:
- Regulatory Affairs Directors, Managers, and Associates responsible for IND, NDA, BLA, or 510(k) submissions
- Drug Development Leaders overseeing pre-clinical to Phase III programs
- Clinical Operations and Clinical Trial Managers navigating data integrity and AI-assisted study reporting
- Quality Assurance and Compliance professionals developing AI governance policies
- Medical Writers drafting AI-assisted clinical study reports, narratives, and labeling
- CMC and Pharmacovigilance professionals exploring AI for safety signal detection and reporting
- Regulatory IT and Digital Transformation teams evaluating or implementing AI platforms
- Consultants and CRO professionals advising clients on AI adoption in regulatory contexts
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
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