AI in GxP: Opportunities, Challenges and Industry Guidance
Insights on current AI trends, EMA & FDA guidance, EU AI Act and more

Moderators:
Stefan Münch, VP Validation & Qualification, Körber Pharma Consulting | Member of GAMP® D-A-CH Steering Committee, ISPE™

Donncadh Nagle, CQV Consultant, Jacobs Engineering | Lecturer, TU Dublin

Guest Speaker:
Martin Heitmann, Senior Manager, d-fine | Secretary of GAMP® Global Special Interest Group Software Automation & Artificial Intelligence, ISPE™

Webcast Overview:
The integration of Artificial Intelligence (AI) into GxP-regulated environments is accelerating, prompting regulators to establish clear frameworks and expectations for regulated organizations. EMA’s “Reflection paper on the use of artificial intelligence in the lifecycle of medicines “, FDA’s draft guidance titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products”, and the EU AI Act introduce new requirements and considerations that will influence how AI-enabled systems are developed, tested, and implemented in the life sciences sector. Understanding these regulatory initiatives is crucial for GxP professionals aiming to maintain quality, ensure compliance and leverage AI effectively. Join us for a podcast-style Q&A session with industry experts as we dissect these regulatory developments and their practical implications.

 What Attendees Will Learn:

• Key Provisions and Implications: Understand the main implications of the EU AI Act for the life sciences sector, which establishes a comprehensive legal framework for AI, and the FDA’s and EMA’s draft guidance, which provide recommendations for the use of AI in regulatory decision-making for drugs and biological products, and guidance on the use of AI in the medicinal life cycle, respectively.
• Regulatory Perspectives: Gain insights into how European and U.S. regulators view and approach AI/ML-driven systems in pharmaceuticals, medical devices, and quality management.
• Validation Best Practices: Learn strategies for validating AI-enabled systems to meet compliance standards amidst evolving global regulations.
• Real-World Applications: Hear case studies illustrating successful AI adoption in GxP environments, including challenges faced and solutions implemented.
• Proactive Compliance Strategies: Discover actionable steps to stay ahead of AI regulatory changes and ensure your practices are future-proof.