Help

Life Sciences 2019: Navigating Legal Challenges in Drug & Device Industries: PLI Boston Groupcast

  • Product Number: 2200059VC1
  • CLE Credits, earn up to:
    7 substantive credits, 0 ethics credits CLE Credit Note
  • Add to Favorites List

Choose Date/Location:

  • Product Description
  • Agenda & Materials
  • Pricing
  • Product Description

    Product Description

    Join our 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. This program will cover the explosive growth of digital health and the legal issues that come with it; the latest regulatory developments at the FDA; as well as recent trends in pricing and reimbursement, effective compliance and investigation practices, and enforcement. 

    What You Will Learn

    • Explore Hot Topics in Regulatory and FDA Law
    • Learn about Recent Developments in Digital Health
    • Examine Enforcement Trends impacting the Drug and Device Industries
    • Survey Top Legal Issues in Pharmaceutical Pricing and Reimbursement
    • Review Effective Compliance Programs and Investigations


    Who Should Attend

    This program is designed for attorneys and allied professionals who counsel pharmaceutical and life sciences companies.

    Program Level: Overview

    Intended Audience: Attorneys and allied professionals who counsel pharmaceutical and life sciences companies.

    Prerequisites: An interest in the law and business of pharmaceutical and life sciences companies.

    Advanced Prep: None

  • Agenda

    Agenda & Materials

    • 9:00 AM EDT

      Opening Remarks

    • 9:15 AM EDT

      Hot Topics in Regulatory and FDA Law

      • Legislative and Regulatory Developments for Diagnostics • Legislative and Regulatory Developments for Opioids • FDA Enforcement Update
    • 10:30 AM EDT

      Networking Break

    • 10:45 AM EDT

      Recent Developments in Digital Health

      • Key Regulatory Considerations and Developments in Digital Health • Digital Health Combination Products • Digital Heath – AI, IoT, IP and Who Owns the Data • Privacy and Cybersecurity Issues in Digital Health
    • 11:45 AM EDT

      Top Legal Issues in Pharmaceutical Pricing and Reimbursement

      • Pricing Transparency – State and Federal Action • Innovative Contracting – Value-based and other options (including impact on price reporting • Patient Issues – Co-pays & Deductibles • A closer look at PAMA (Protecting Access to Medicare Act) • Alternative payment models • Impact of implementation of the Medicare Access and CHIP Reauthorization Act (MACRA)
    • 1:00 PM EDT

      Lunch

    • 2:15 PM EDT

      Enforcement Trends impacting the Drug and Device Industries

      • False Claims Act • Anti-Kickback Statute • Off-label promotion • Individual liability
    • 3:30 PM EDT

      Networking Break

    • 3:45 PM EDT

      Effective Compliance Programs and Investigations: A Hypothetical

      • OIG and CMS expectations and requirements • Strategies for assessing compliance program effectiveness • Investigation best practices • Privilege issues • Self-disclosure
    • 5:00 PM EDT

      Adjourn

    Please Note

    MCLE webcasts are delivered completely online, underscoring their convenience and appeal. There are no published print materials. All written materials are available electronically only. They are posted 24 hours prior to the program and can be accessed, downloaded, or printed from your computer.

  • Pricing

    Fees

    • $1,850.00 - All Registrants
TOP