MARSQA Webinar: AI in GxP: A Complicated Story of Laws, Regulations, and Governance Practice
Presented by:
Nikodem Latocha This online webinar will be given via Zoom.
“AI in GxP: A Complicated Story of Laws, Regulations, and Governance Practice” is a deep dive into the complex landscape of the dynamic balance where technology confronts rigorous laws, regulations, and unique industry standards. This presentation will show the current state of global laws, including but not limited to the AI Act, technology standards, like ISO 42001 AI Management System, unique regulations in the pharmaceutical sector, combined with data protection aspects as well as ethical principles, creating a challenging homeostasis for structured AI governance programs. The presentation will also provide a unique focus on the use cases from other industries that are already successfully implementing AI systems and what the pharmaceutical industry can learn from them.
Participants will learn about:
- The European Union’s AI Act and similar laws and their implications in a highly regulated environment
- ISO42001’s AI Management System standard and its practical implementation
- AI Risk Management frameworks that balance technological advancement with patient safety, product quality, and data integrity
- Real-world case studies demonstrating successful AI governance in different industries
- Emerging compliance strategies that transform regulatory challenges into competitive advantages
- Possible ways the work of Quality personnel in pharma and biotech may change in the near future.
You’ll walk away with a strategic roadmap for responsible AI governance that meets the highest standards for safety, efficacy, and ethical considerations.
Even though this event is complimentary for members, you must continue to checkout to complete your registration. After registering, you will receive further instructions on how to access the webinar via email in 1-2 business days.