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The Evolving Global AI Regulatory Landscape: Recent Developments and Practical Insights for Clinical Trials

 
  January 30, 2025  
     
 
Xtalks, Online
2025-03-20


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AI Act, which entered into force on August 1, 2024; the US Food and Drug Administration (FDA)’s January 2025 updated draft guidance for the Use of AI to Support Regulatory Decision-Making for Drug and Biologic Products; as well as emerging AI regulations in other parts of the world and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 analyze risk principles driving global regulatory developments and provide insights about how the evolving AI regulatory landscape impacts clinical trial workflows and data capture, particularly as concerns important issues like patient safety, data accuracy and the overall efficiency of the clinical development process.

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.

Register for this webinar to understand the evolving AI regulatory landscape and drive innovation in clinical trials.

Keywords: Clinical Trials, Clinical Research, CRO, Clinical Data, Regulatory, Regulatory Affairs, Regulatory Compliance, Pharmaceutical Regulation, Clinical Trial Management, Artificial Intelligence, AI
 
 
Organized by: Xtalks
Invited Speakers: Todd Rudo, MD, Executive Vice President, Chief Medical Officer, Clario
Lauren Misztal, Senior Vice President, General Counsel, Clario
Marko Topalovic, PhD, Senior Vice President, Chief AI Officer, Clario
 
Deadline for Abstracts: 2025-03-20
 
Registration: Free Registration
E-mail: tristan@xtalks.com
 
 
   
 
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