“Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies

May 01, 2024

Capital Factory Austin TX 2

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.

Program Schedule:

9:00 – 9:30am Tips for Assessing Medtech Company Maturity

Nate Downing will present an overview on what companies need to consider when formulating a strategy for their FDA-regulated products.

9:30 – 10:00am Exploring Enforcement Trends in Healthcare Compliance

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.

10:30 – 10:45am BREAK

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.

11:15 - 12:00pm Panel Discussion: In-House Counsel Perspectives

Mark Gardner will moderate a panel of in-house attorneys to discuss the topics of the day.