Artificial intelligence (AI) is transforming how GxP-regulated areas of life sciences operate. As AI grows ever more capable, people are rethinking humans’ role in an increasingly technology- and data-driven world. With key competencies of AI literacy and data understanding being of paramount importance, strong critical thinking skills become ever more essential for effective oversight.
ISPE’s upcoming 2026 ISPE AI in Life Sciences Summit – Powered by GAMP®, taking place 23–24 June in Boston, Massachusetts, will bring together a diverse group of professionals from across the pharmaceutical and tech industry to address the nascent opportunities and challenges for applying artificial intelligence in the...
The life sciences industry stands at a pivotal moment. Artificial intelligence (AI) and generative models are rapidly moving from experimental environments into GxP-regulated workflows. At the same time, regulatory expectations, including those reflected in the EU Annex 22 Draft and recent US Food and Drug Administration guidance, are evolving, with increased scrutiny on data integrity, model...
The new ISPE GAMP® Guide: Artificial Intelligence provides a comprehensive, state-of-the-art best practice framework to efficiently and effectively achieve high-quality AI-enabled...
Informed consent aims to provide clinical trial participants with transparent education about the trial’s objectives, potential risks and benefits, and procedural requirements. As clinical trial designs evolve to include decentralized and adaptive elements, the informed consent process becomes increasingly complex. In response, this article explores the potential application of AI-powered...
