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Life Sciences Compliance Boot Camp

American Conference Institute
Hyatt Regency Mission Bay Spa and Marina - San Diego, CA

Sheppard Mullin Partner Pamela J. Naughton will be presenting at American Conference Institute's Life Sciences Compliance Boot Camp, June 28-29, 2010, at the Hyatt Regency Mission Bay Spa and Marina in San Diego, CA.

Monday, June 28, 2010
9:30 a.m. - 11:00 a.m.

Building and Structuring A Compliance Infrastructure for Life Sciences Companies: Legalities and Ethics

Pamela J. Naughton
Partner, Sheppard Mullin Richter & Hampton LLP
(San Diego/Del Mar, CA)

George Ng
Senior Counsel & Director of Intellectual Property, Spectrum Pharmaceuticals, Inc.,
(Irvine, CA)

T. Reed Stephens
Partner, McDermott Will & Emery LLP
(Washington, DC)

Presentation topics will include:

  • Learning to use the seven elements to design a flexible and global program that can adapt to corporate growth
    • thinking of compliance in global terms – i.e., integral and comprehensive as well as potentially international
  • Collaborating with existing departments and corporate functions to establish compliance structure and get necessary “buy-in”
    • importance of top brass taking ownership of compliance program
  • Examining compliance program implementation vis-a-vis existing company structure
    • which person/department is the best choice to start a compliance program?
      • Legal?
      • HR?
  • Appointment of a compliance officer
      • understanding why this may be the most critical component of a compliance program
      • review of compliance officer provisions in recent CIAs
    • special considerations for small to mid-sized companies
    • reporting structure for compliance
      • to whom should the compliance officer report?
        • Board of Directors? Legal?
      • and to whom should the CO never report?
  • Where should the compliance department ultimately be placed?
    • can compliance objectives/duties be shared among various departments?
      • separation of departmental duties and implementation of safe guards
    • dotted line reporting responsibilities
      • compliance liaisons
  • Why compliance should be separate from legal

For more information or to register for this event, please click here. 


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