The Evolving Global AI Regulatory Landscape: Recent Developments and Practical Insights for Clinical Trials
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AI Act, which entered into force on August 1, 2024; the US Food and Drug Administration (FDA)’s January 2025 updated draft guidance for the Use of AI to Support Regulatory Decision-Making for Drug and Biologic Products; as well as emerging AI regulations in other parts of the world and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.
Session information:
Time:
- 11:00 a.m. – 12:00 p.m. ET (NA-East)
- 16:00 – 17:00 GMT (UK)
- 17:00 – 18:00 CET (EU-Central)
Abstract:
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AI Act, which entered into force on August 1, 2024; the US Food and Drug Administration (FDA)’s January 2025 updated draft guidance for the Use of AI to Support Regulatory Decision-Making for Drug and Biologic Products; as well as emerging AI regulations in other parts of the world and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.
Register for this webinar to understand the evolving AI regulatory landscape and drive innovation in clinical trials.
What You Will Learn:
- The current global AI regulatory landscape, including the new EU AI Act; FDA’s recent updated draft guidance and emerging AI regulations in other parts of the world
- Regulatory concerns regarding clinical development including fairness, participant privacy and safety, data accuracy, model transparency and accountability for AI usage
- Considerations for integrating AI-enabled technologies into clinical trial workflows considering current regulations and guidance
Speakers
Todd Rudo, M.D.
Executive Vice President, Chief Medical Officer at Clario
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.
Lauren Misztal
Senior Vice President, General Counsel at Clario
Lauren Misztal is a business-oriented and solutions-driven legal advisor who draws on close to two decades of experience successfully resolving complex legal and regulatory issues. Prior to joining Clario, Lauren held senior legal and compliance roles at Mallinckrodt Pharmaceuticals and McKesson Corporation and was an associate and Of Counsel at Quinn Emanuel LLP. Lauren began her legal career as a trial attorney at the US Department of Justice after clerking for a federal judge in Washington, DC. She received her JD from Georgetown University Law Center and bachelor’s degree from Georgetown University. Prior to attending law school, Lauren was a financial analyst at Goldman Sachs. As Clario’s General Counsel, Lauren focuses on setting the Company’s global legal strategy and leads teams dedicated to supporting our commercial relationships, counseling on data privacy regulations and mitigating risk.
Marko Topalovic, Ph.D.
Senior Vice President, Chief AI Officer at Clario
Marko Topalovic is responsible for overseeing and leading the strategic direction of artificial intelligence initiatives, including leadership of AI R&D functions at Clario. He has over 13 years of AI and Data Science experience in academia and industry, with a strong focus on the healthcare and life science industries. Previously, Marko served as Chief Executive Officer of ArtiQ, a spin-off from the Belgian University KU Leuven, and a leading developer of artificial intelligence tools used to diagnose and monitor patients with respiratory conditions. Marko holds a PhD in Biomedical Sciences from KU Leuven, where he developed state-of-the-art AI-based algorithms for interpreting pulmonary function tests. He also has business training from Flanders Business School and an MSc in Computer Sciences from the University of Belgrade. Marko has published multiple papers and received several awards for his scientific work and is passionate about connecting the fields of medicine and technology to augment healthcare with innovative solutions.