Pre-Conference Workshop Day
Tuesday, July 15, 2025
08:00 am Check In & Breakfast
Workshop A | 9.00am - 12.00pm | Building & Developing AI Models Using Different Validation Techniques to Maintain Compliance
How do you validate AI? This is a question that remains unanswered in this industry.
With the unavoidable growth of AI, it is imperative to understand validation of AI. How can we ensure ongoing compliance with the iterative nature of AI? How do you ensure it remains fit for intended use and not going to impact patient safety? How can we make it more reliable?
This workshop will cover:
- Understanding the critical role of AI validation in ensuring compliance with
regulatory standards and maintaining data integrity - Hands-on discussion on various validation approaches and when to apply them toAI models
- Developing a framework for continuous monitoring, performance evaluation, and revalidation of AI models to maintain compliance over time
Workshop Leader:
Jeremiah Genest
Senior Director - Quality Technical & Risk
Evotec
12:00 pm Lunch Break & Networking
Workshop B | 1:00pm - 4:00pm | Strategies to Maximize Regulatory Compliance When Deploying AI to Seamlessly Improve Overall GxP Procedures
How much clarity is there around AI regulations? What are the internal processes to ensure this is communicated across all stakeholders? Are there systems in place to
identify gaps in your AI deployment?
This workshop will cover:
- Strategies for aligning AI deployment with existing GxP procedures to improve
efficiency while maintaining compliance - Practical steps for establishing AI development, validation, and testing processes that meet regulatory requirements
- Leveraging AI to streamline real-time monitoring, ensuring ongoing adherence to GxP standards and proactive risk mitigation
Workshop Leader:
Munya Mafemba
Director, Regulatory Compliance R&D –Technology
Signant Health
Ryan Pehrson
Vice President & Global Head of DevOps & Cloud
Takeda