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  • Financial Disclosure by Clinical Investigators (21 CFR Part

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Jul 09, 2013 10:00 AM
  • End Time:
  • Tuesday - Jul 09, 2013 11:30 AM
  • Location:
  • Online
  • This webinar on FDA's financial disclosure requirements for clinical investigators will review the regulations under 21 CFR Part 54, explain the nuts and bolts of financial disclosure and and answer any questions you might have on how to remain compliant with these regulations.

    Why Should You Attend:

    This session will provide an understanding of these methods and show how to implement them to counter the appearance of potential bias. It’s important that FDA considers the financial disclosure information within the context of the methods the sponsor has used to minimize bias and does not view financial interest in itself as harmful.

    Finally the presenter will review how the FDA evaluates the disclosure information, what actions it may take, and when FDA may publicly disclose equity interests under transparency policy.

    Areas Covered in the Webinar:

    - Why financial disclosure is necessary for FDA approvals and how the guidelines were developed.
    - Actual, apparent, or potential conflicts of interest.
    - Subtle ways in which bias can influence judgment and objectivity.
    - Nuts and bolts of financial disclosure: Collecting, Reporting, Monitoring and verifying compliance.
    - How the FDA evaluates financial disclosure information.

    Learning Objectives:

    - Participants will understand the rationale for collecting financial disclosure.
    - Participants will have resources for continued support of financial disclosure questions.
    - Participants will achieve a higher level of confidence in their approach to financial disclosure requirements.
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