6-Hour Program

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Overview

Join PLI’s expert faculty of life sciences practitioners, in-house counsel, government regulators, and prosecutors as we examine the current state of life sciences law and what the future might hold for the pharmaceutical, biologics, device, and health technology industries. This program will cover the broad range of issues confronting the life sciences industry: trends and best practices in FDA premarket review; recent developments in scientific discourse and promotional guidelines affecting FDA-regulated companies; the pricing and reimbursement landscape; and federal and state enforcement of the Food, Drug, and Cosmetic Act and health care fraud and abuse laws - including the federal False Claims Act, the federal Anti-Kickback Statute, the Stark law, and similar state laws.

What You Will Learn

  • The legal framework for promoting drugs, biologics, and medical devices
  • Legal requirements related to off-label promotion
  • Recent developments concerning medical product regulation
  • Pricing and reimbursement for drugs and devices
  • Trends in health care fraud enforcement
  • Best practices for compliance program effectiveness and internal investigations

Credit Details