Episode 3: Annex 22 Update: A Deep Dive into the EU's New Annex 22 on Artificial Intelligence

The European Union has introduced Annex 22, a landmark regulatory guideline to ensure the safe and GMP-compliant use of Artificial Intelligence (AI) and Machine Learning (ML) in pharmaceutical manufacturing. As the industry embraces digital transformation, this draft regulation outlines critical requirements - from model validation and expectations for test execution data to explainable AI requirements.

In this session, you’ll gain a structured overview of Annex 22, practical interpretations, and clear recommendations for successful implementation in your organization.

Why Attend?

✅ Understand the regulatory expectations for AI/ML in pharmaceutical environments
✅ Learn how to apply Annex 22 to your systems, SOPs, and validation frameworks
✅ Avoid compliance risks by aligning AI deployments with GMP principles
✅ Enable innovation safely with structured, auditable AI processes
✅ Engage with industry experts actively working on Annex 22 interpretation and implementation.