AdvaMed partners with Hogan Lovells for this free webinar on best practices for AI-based technologies in FDA marketing submissions.
Join AdvaMed and Hogan Lovells for this free webinar to explore the essentials of AI-based technology in FDA marketing submissions. We’ll delve into the specific requirements and data necessary for support, including a focused look at the FDA’s recent guidance on predetermined change control plans (PCCP). Additionally, we’ll tackle the critical elements of marketing submission for AI-based devices, emphasizing algorithm training and software requirements.
Learn from examples of successfully cleared AI-based devices with supporting validation data, and gain insights into approved PCCPs. Our discussion will also highlight best practices and common pitfalls, drawing on extensive practical experience in drafting submissions for AI-based medical devices. Join us to enhance your understanding and strategy for navigating FDA submissions.
Meet the Speakers
Kelliann Payne, Partner, Hogan Lovells
Kelliann Payne’s science education and background in the medical device industry allow her to quickly understand emerging medical device technology, including digital health products, and informs her current focus on related legal and business issues. Her experience includes the development, regulation, advertising, and litigation of medical devices and digital health products, including machine learning-based clinical decision support software.
Kelliann drafts premarket submissions for diagnostic and therapeutic medical devices, evaluates and formulates applicable regulatory strategies, and reviews the accuracy of marketing claims. She helps companies in their preclinical and clinical programs and leads due diligence reviews for investments and acquisitions.
In her role as Assistant General Counsel at QVC, Inc. from 2013 to 2014, Kelliann counseled internal clients on Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulations applicable to health, wellness, beauty, and cosmetic products.
As a consultant for the medical device industry, she assisted companies with complex regulatory challenges and strategies for marketing innovative products. Kelliann majored in biology prior to pursuing a career in law.
Alex Smith, Director of Regulatory Sciences, Global Regulatory, Hogan Lovells
Alex Smith understands the pressure medical device and pharmaceutical companies around the world face when working with the U.S. Food and Drug Administration (FDA) to resolve premarket and postmarket technical compliance concerns within the ISO/USP/QSR and cGMP frameworks. Alex is RAC certified for FDA Drugs and Devices by the RAPS organization.
As a former process and software engineer at GlaxoSmithKline and Human Genome Sciences, Alex’s primary practice involves assisting companies with medical device and pharmaceutical submissions that involve software such as AI/ML submissions and 21 CFR Part 11 concerns. During his time at Hogan Lovells, Alex has provided software architecture and lifecycle advice on substantial variety of devices such as AI radiological imaging, 3D adaptive manufacturing, infusion pumps, and individualized vaccines involving AI.
In addition to providing software services, Alex frequently works with companies around the world to avoid and respond to QSR and cGMP enforcement from FDA and Health Canada. Alex has assisted companies with not only substantial quality and regulatory re-organization following Warning letters and import alerts, but has also provided direct technical advice such as developing master validation plans and validation execution for lab and manufacturing equipment such as HPLC, endotoxin, cell culture, sterilizers and plant automation.
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