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Kathleen McDermott Presents at the American Conference Institute's "Managing Legal Risks in Structuring & Conducting Clinical Trials" Conference in Boston

Event Date(s): 09/26/2007 
Event Location(s): Boston, MA 
Presenter(s): Kathleen McDermott 
Event Host(s): American Conference Institute 
Event Description: Sonnenschein partner Kathleen McDermott will present "Managing Conflicts of Interest in Clinical Trials in Order to Preserve Scientific Integrity" at the American Conference Institute's Managing Legal Risks in Structuring & Conducting Clinical Trials Conference.

The presentation will explore the following points of discussion:

  • Improving conflict of interest (COI) identification, disclosure, and management
  • Tailoring procedures for resolving conflicts when they are individual vs. institutional
  • Determining what is a “significant financial interest” in light of differing standards in agency guidances
    • NIH/NSF
    • FDA
  • Ensuring full disclosure of a COI to all appropriate parties
  • Mitigating the conflict’s impact on the conduct or results of the trial
    • modifying interest/commitment
    • using the Chinese wall strategy
  • Avoiding liability based on conflicts of interest through proper management
  • Ensuring seamless execution of the company’s comprehensive COI policy