AIforPharma.org

(EU)
‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;

Source: EU Regulation 2024/1689

***

(US / FDA) A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments. Artificial intelligence systems use machine- and human-based inputs to perceive real and virtual environments; abstract such perceptions into models through analysis in an automated manner; and use model inference to formulate options for information or action.

Source: 15 U.S.C. 9401(3).

Welcome to AI for Pharma

Artificial Intelligence is rapidly transforming the pharmaceutical industry — from drug discovery and manufacturing to quality systems, pharmacovigilance, and regulatory decision-making. At the same time, it raises fundamental questions about compliance, data integrity, validation, and responsibility.

AI for Pharma was created as a space to explore these changes in a practical, regulation-aware, and industry-focused way. The goal of this blog is to:

• Share recent news and developments related to AI in the pharmaceutical industry
• Discuss regulatory expectations (GxP, data integrity, validation, EU AI Act, FDA perspectives, etc.)
• Translate complex AI concepts into clear, usable insights for quality, manufacturing, and regulatory professionals
• Highlight realistic use cases, risks, and limitations — not hype

This initiative is particularly focused on compliance-critical environments, where innovation must coexist with:

• Patient safety
• Product quality
• Regulatory accountability

AI has enormous potential, but in pharma it must be understood, governed, and implemented responsibly.

I hope this blog will become a useful and interesting resource for:

• Quality and compliance professionals
• Manufacturing and validation experts
• Regulatory affairs specialists
• Anyone interested in the intersection of AI and pharmaceutical regulations

This is just the beginning. Future posts will cover examples, regulatory interpretations, lessons learned, and emerging trends.

Welcome — and thank you for reading!