PLI's Life Sciences 2023: Navigating Legal Challenges in Drug and Device Industries

9:00 am - 5:00 pm ET

What are key areas of compliance focus for FDA as the agency emerges from the public health emergency and ramps up inspections and enforcement oversight? How are laws and regulations adapting to use of digital technologies like AI/ML, large language models (“chat”), and the metaverse in the life sciences industry? How are new drug pricing authorities being implemented and how is the legal landscape for coverage and reimbursement changing? What are the key aspects of an effective compliance program?

Laura Laemmle-Weidenfeld, a partner in the Firm's Health Care & Life Sciences Practice, will join PLI's faculty of life sciences practitioners, in-house counsel, government regulators, and educators, to examine the current state of life sciences law and what the future might hold. This program will cover the explosive growth of digital health and the legal issues that come with it; the latest developments in FDA compliance priorities; as well as recent trends in pricing and reimbursement, effective compliance and investigation practices, and enforcement.

TOPICS

• FDA reform: what to expect from the FDA user fee reauthorization legislation
• Recent developments, key regulatory considerations, and anticipated regulatory developments in regulation of digital health, including AI/ML
• Market access issues for innovative medical products, including developments from the Inflation Reduction Act
• Compliance program effectiveness and investigation best practices

  
  

REGISTRATION & CLE CREDITS

Registration for this event is required. For CLE credit information and to register, visit the Practising Law Institute website.