ANNEX 22 Update: A Deep Dive into the EU’s New Annex 22 on Artificial Intelligence

Description:

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.

Agenda

1. Introduction & Background
2. Scope and Exclusions
   – What AI models are permitted – and which are excluded from critical applications
3. Core Requirements Across the Model Lifecycle
   – From data standards and acceptance criteria to monitoring and change control
4. Impacts on SOPs & Quality Systems
   – Practical guidance on updating procedures and documentation
5. Q&A and Discussion

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

Click here to register for the free webinar: https://www.bigmarker.com/gxp-cc/annex-22-update-a-deep-dive-into-the-eu-s-new-annex-22-on-artificial-intelligence-e431c759325483f14423c698