AI in Regulatory Affairs: Use & Lessons

AI in Regulatory Affairs: Use & Lessons
Members of the TOPRA IN France Community Steering Group are pleased to invite you to explore practical AI applications in regulatory affairs.






Date: Thursday 26 June 2025
Time: 15:00 - 16:00

Industry experts Cary Smithson and Meelis Lootus will discuss artificial intelligence (AI) fundamentals, current technologies; and real-world applications from the Drug Information Association (DIA) Regulatory Information Management (RIM) AI Survey. Learn how AI transforms regulatory intelligence, submissions, and authoring processes, and discover implementation best practices, governance frameworks, and solutions to common challenges. The presentation will include a detailed case study and a live demonstration of AI-powered submission authoring. Join us to understand how AI can enhance efficiency and quality in your regulatory operations while maintaining compliance standards.

Benefits for participants

        - In-depth Market Insights: Discover current AI adoption trends in regulatory affairs based on comprehensive                     industry survey data.
        - Stay Updated: Learn about the latest AI technologies transforming regulatory processes and documentation                     workflows.
        - Practical Strategies: Gain actionable implementation frameworks to successfully integrate AI into your                               regulatory operations.
        - Expert Guidance: Benefit from specialized knowledge on AI governance, compliance considerations, and best                 practices from industry leaders.

Presenter(s)

Meelis Lootus, CEO and Founder, Tehistark
Meelis is the Founder and CEO of Tehistark, where he leads the development of AutoDossier—an artificial intelligence (AI) content authoring platform to plan and write regulatory dossiers with leading biotechnology, pharmaceutical, and CRO/consultant partners. Previously, he served as Director of AI Engineering at Sharecare, developing AI workflows for pharmaceutical and health insurance companies. He is also an expert in clinical trial innovation, contributing to guidelines on decentralised clinicals and digital biomarkers in an Institute of Electrical and Electronics Engineers (IEEE) working group. He has 15 years of direct AI experience—including a Ph.D. on spinal MRI analysis automation from the University of Oxford’s Visual Geometry Group (VGG)lab.

Cary Smithson, Managing Partner, LeapAhead
Cary Smithson is the Managing Partner at LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, simplify information management and the use of technology.  Her areas of expertise include regulatory information management, artificial intelligence, data strategy / governance, e-submissions, R&D and GxP content management, Clinical, GxP quality / compliance, IT strategy, enterprise architecture, Agile, business process optimisation and project / program management.  Cary leads the RAPS AI Community, DIA RIM Working Group and DIA RIM Intelligent Automation Team and regularly serves as an industry thought leader.

The main webinar presentation will run for approximately 50 minutes, which will then be followed by a Q&A session. 

Pricing

TOPRA Members: Free
Non-member: £45
When
26/06/2025 15:00 - 16:00
Where
ONLINE
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