[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with... Gardard Law is hosting a half-day CLE event in Austin, Texas, on May 1st, aimed at learning about regulatory, compliance, and privacy challenges in the FDA-regulated industry. The event will be held at the Capital Factory in Austin or online, with attendees to learn about risk management strategies, regulatory issues, and enforcement trends. The program includes an overview of healthcare compliance fraud and abuse trends, including recent Anti-Kickback Statute (AKS) and False Claims Act (FCA) settlements, CMS Sunshine investigations, state enforcement, and DOJ/OIG news. Nate Downing will provide an overview on what companies need to consider when formulating a strategy for their FDA regulated products. David Graham will discuss trends in Class Action and Product Liability Litigation for Medtech, and how the challenge to Chevron deference might impact regulatory action and litigation.
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Опубликовано : месяц назад от в Health
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy challenges in the FDA-regulated industry. Learn from transactional and litigation attorneys, sharpen your risk management strategies, and stay ahead of enforcement trends. This concise half-day program will deliver Texas-sized content and actionable insights, ending with an engaging Q&A session with industry leaders.
Nate Downing will present an overview on what companies need to consider when formulating a strategy for their FDA-regulated products.
Amanda Johnston will provide an overview of the latest healthcare compliance fraud and abuse enforcement trends and hot topics, including recent Anti-Kickback Statute (AKS) and False Claims Act (FCA) settlements, CMS Sunshine investigations, state enforcement, as well as DOJ/OIG news.
10:00 – 10:30am Tips on New State Privacy Laws and HIPAA
Paul Rothermel will provide an overview of how new state privacy laws are impacting device and drug makers and how these laws interact with HIPAA.
10:45 – 11:15am Trends in Class Action and Product Liability Litigation for Medtech
David Graham will explore the latest and most impactful decisions in medtech litigation related to defective products and labeling. He will also discuss how the challenge to Chevron deference might impact regulatory action and litigation in the future.
Mark Gardner will moderate a panel of in-house attorneys to discuss the topics of the day.
Темы: FDA