Past Events

WHEN: December 13, 2016 at 5:30pm EST
WHERE: Cooley LLP, Grace Building, 1114 Avenue of the Americas, New York, NY 10036
  • Andy Roth
    Partner
    Cooley LLP (New York, NY)
  • Brian Smith-Sweeney
    CISO
    Columbia University Medical Center

What is it about?

  • What is keeping healthcare CEOs up at night? The threat of cyber attacks. Cybersecurity is one of the most critical issues facing healthcare executives across the ecosystem. From HIPAA breaches to medical identity theft to safeguarding intellectual property, protection from cyber attacks has become an urgent imperative. On October 27, Cooley will host a panel discussion on cybersecurity that will cover the current legal, regulatory, business, and technological environment, and explore options for effective management for senior management and boards of directors.

Please register here.


ACI’s 16th Annual Drug Pricing Master Course

Developing a Culture of Pricing Compliance – Strategies for Avoiding OIG and DOJ Scrutiny of Drug Pricing Practices

WHEN: November 2, 2016 at 3:45pm EST
WHERE: Park Lane Hotel, 36 Central Park S, New York, New York 10019

What is it about?

  • Understanding the current environment for compliance and enforcement related to pricing issues
  • Identifying compliance guidance for pricing issues
  • Anatomy of a government False Claims Act and Anti-Kickback investigations
  • Identifying the roles of CMS, OIG and DOJ relative to pricing, rebates and enforcement
  • Acknowledging the OIG’s direct pricing authority to determine and force WAMP (widely available market price) as an alternative to ASP
  • Comprehending the OIG’s indirect impact on pricing
  • Coupons
  • Part D rebates and administrative fees
  • Assessing potential anti-kickback violations with treatment of payment support programs for price reporting
  • Bolstering compliance programs and internal practices to minimize the risk of investigations
  • Analyzing enforcement trends
    • False claims act cases
    • Bundling cases
  • Responding to government investigations
  • Assessing the collateral consequences of investigations

Please register here. 


The Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress

R&D Compliance: Introduction, Panel Discussion and Q&A

WHEN: October 20, 2016 at 10:30am EST
WHERE: Mandarin Oriental, 1330 Maryland Avenue SW, Washington, D.C.
  • Natasha Leskovsek 
    Partner
    Cooley LLP (Washington, D.C.)

  • Sue Seferian
    Global R&D Health Care Compliance Office
    Johnson & Johnson (New Brunswick, NJ)

WHEN: October 19, 2016 at 5:30pm PST
WHERE: Cooley LLP, 3175 Hanover Street, Palo Alto, CA

What is it about?

  • Cooley is sponsoring CLSA’s inaugural Corporate Counsel Committee meeting on October 19 and will feature Regulatory Immersion Roundtable Series, session# 11 led by Cooley partners Wendy Goldstein and Natasha Leskovsek.
  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization. All CLSA members interested in joining the committee are invited to attend.
WHEN: August 9, 2016 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

What is it about?

  • Cooley’s Regulatory Roundtable Immersion Series is an invitation-only series for senior company executives and investors.  It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.