Summary:
This article discusses the evolving global AI regulatory landscape, highlighting the EU AI Act and FDA guidance for AI in drug development, focusing on patient safety and efficiency in clinical trials.
Original Link:
Original Article:
As new and novel uses for artificial intelligence (AI) proliferate, regulatory bodies worldwide are establishing frameworks and guidance to govern the safe and ethical use of this innovative technology.
This webinar will address recent developments in the global AI regulatory landscape such as the clinical trial aspect of drug development, including the new European Union (EU) AI Act, which entered into force on August 1, 2024; the US Food and Drug Administration (FDA)’s January 2025 updated draft guidance for the Use of AI to Support Regulatory Decision-Making for Drug and Biologic Products; as well as emerging AI regulations in other parts of the world and their potential impact on clinical trials.
The speakers will examine the risk principles behind global regulatory changes and shed light on how the evolving AI regulatory landscape affects clinical trial workflows and data capture, with a focus on patient safety, data accuracy, and overall efficiency in clinical development.
The webinar will include a discussion about Clario’s AI Responsible Use Principles, which provide an example of how to proactively address regulatory concerns in the clinical trials context and take steps to develop, implement and use AI in a way that is fair, transparent, safe and ethical.