From Compliance to Competitive Advantage: How Regulatory Affairs Can Operationalize the EMA/FDA AI Principles
A New Regulatory Blueprint for AI In January 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly published the Good AI Practice in Drug Development — 10 principles. This document outlines ten principles designed to establish a framework for effective practices as artificial intelligence becomes increasingly integrated into the […]
AI for Clinical and Regulatory Documents: From Hype to Value
The allure of Artificial Intelligence (AI) is hard to ignore. From automating repetitive tasks to deriving insights that drive strategy, organizations everywhere are sprinting to embrace AI solutions. According to Gartner, by 2026 60% of organizations will abandon AI projects unsupported by AI-ready data. But as more companies race to deploy AI, many overlook fundamental […]
Top Professional Associations for Clinical and Regulatory Affairs
Professional associations are vital channels for knowledge sharing, networking, and staying on top of emerging trends in any industry. In clinical and regulatory affairs, these organizations play a pivotal role in shaping policies, providing educational resources, and fostering collaboration among professionals. Here’s a look at some of the leading associations in this field. 1. The […]