The Machines Are Coming (And Lawsuits Too): Mitigating Risks of Device Design, Manufacture, and Sale Amidst the AI Revolution
November 2, 2023
11:00 AM – 12:00 PM
AdvaMed and King & Spalding are excited to bring you this free webinar exploring recent regulatory updates impacting AI and machine learning in medtech.
The Machines Are Coming (And Lawsuits Too): Mitigating Risks of Device Design, Manufacture, and Sale Amidst the AI Revolution
November 2, 2023
11:00 AM – 12:00 PM
The Machines Are Coming (And Lawsuits Too): Mitigating Risks of Device Design, Manufacture, and Sale Amidst the AI Revolution
November 2, 2023
11:00 AM – 12:00 PM
Artificial Intelligence and machine learning technologies have a rapidly expanding role in the medical device industry. While science often outpaces regulators and the law, both always catch up. This free webinar will provide an overview of recent developments in the regulation of AI and machine learning-enabled devices, share views on the future landscape of AI regulation and litigation, and offer suggestions on how device manufacturers can mitigate regulatory and litigation risk associated with the manufacture and sale of devices developed “in silico.” Register today to ensure you’re up to speed on the latest regulatory policies that will impact your work.
Agenda Topics Include:
- Overview: AI/ML and Medical Devices
- The Evolving Regulatory Landscape
- Legal and Regulatory Risks Associated with Ai/ML
- Risk Mitigation Strategies
In partnership with:
Micha Nandaraj Gallo, Associate, King & Spalding
Micha Nandaraj Gallo is an associate in the firm’s trial and global disputes practice group. Her work focuses on defending clients facing complex product liability and mass tort litigation. Micha is often confronted with the application of traditional tort theories in novel arenas in her practice and enjoys helping clients navigate new challenges and opportunities that arise at this intersection. She has represented clients across a wide range of industries, including pharma, tech, auto, and sports, on tasks big and small.
Amanda J. Klingler, Partner, King & Spalding
Amanda Klingler advises life sciences clients on a wide range of regulatory matters, enforcement actions, civil litigation, investigations, product liability litigation, and compliance counseling. Amanda has significant experience helping clients navigate FDA’s regulation of digital health devices and other innovative areas in FDA law. She works closely with the firm’s product liability team and is experienced handling FDA issues in product liability litigation. Amanda also advises device and drug manufacturers on pre- and post-marketing regulatory activities and strategies.
Mark Sentenac, Partner, King & Spalding
Mark Sentenac represents companies in complex, multi-jurisdiction mass tort litigation targeting a broad spectrum of industries, with particular experience defending medical device and pharmaceutical manufacturers. Mark has extensive experience litigating all phases of mass torts, including coordinating large dockets of cases, working with company and expert witnesses to develop the company’s story, counseling on discovery strategy, and helping try cases. Mark also helps companies with pre-litigation product risk assessments and internal investigations to help companies avoid litigation and minimize their risk.
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