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 Enabled Content Generation for Clinical and Regulatory Documents
What is the current state of AI in clinical and regulatory content? In Part One of our three-part series, we assessed your organization’s AI readiness for automating regulatory and clinical trial document creation. In Part Two, we explored Structured Content Authoring, defining this essential building block to establish modular frameworks representing all the data associated with clinical […]
Structured Content Authoring (SCA) in Clinical and Regulatory Documents
In our previous post, we explored how AI is transforming regulatory and clinical documents, moving from hype to real, measurable value. In this second installment, we take a closer look at Structured Content Authoring (SCA), a foundational capability that enables reuse, traceability, and automation at scale. SCA is more than a technical upgrade. It is […]
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 […]