Quick answer The EU AI Act is the European Union's risk-based regulation for artificial intelligence. It applies to organizations that develop, provide or use AI systems, including pharmaceutical, biotechnology and medical device companies. Complianc...
Quick answer Draft Annex 22 is the EU's proposed GMP guidance for data-trained AI and machine learning (AI/ML) models used in critical pharmaceutical manufacturing applications. It introduces AI-specific expectations for governance, validation, risk ...
In our past training session, “Making AI work for you: everyday wins in QARA”, life sciences expert Martin King taught us how to use AI in quality management to enhance quality processes.
Thanks to the growing use of AI in drug development, pharmaceutical companies can now sift through all that data to spot patterns, predict failures, and make better decisions faster. From finding promising drug candidates to optimizing clinical trial...
The hype of artificial intelligence (AI) is revolutionizing industries such as pharmaceuticals and medical devices, and the regulatory landscape has moved fast to keep pace.
At the time of this updated blog post, regulatory frameworks for Artificial Intelligence (AI) in the pharmaceutical and medical device industries are in place. Since 2023, the conversation has shifted decisively from "what should the rules for AI be?...
Artificial intelligence (AI) and machine learning (ML) are on the verge of transforming healthcare by creating new, vital insights from the vast amount of data gathered during healthcare delivery activities every day. AI/ML-based life science innovat...