Clinical Quality Assurance and Management Policy: Two Case Histories

Written by on Monday, April 2nd, 2007

The event Clinical Quality Assurance and Management Policy: Two Case Histories will be held on Wednesday, April 18, 2007 from 10 to 11:30 a.m. by audio conference.  The event will look at two different case studies on clinical trials and what went wrong and how to avoid it, addressing the following:

  • What corporate decisions occurred?

  • Why did one site close down in response to the FDA enforcement action?

  • Why does corporate management not share the clinical research or the regulatory perspective?

  • What is the required corporate management CQA interface?

  • Where and why did it fail?

  • FDA sponsor obligations – what are they?

  • What is the sponsor’s liability and exposure for FDA enforcement action?

  • How do the concepts of misconduct, fraud, and sponsor due diligence impact the FDA application of enforcement actions?

  • How can CQA enable corporate management to empower the CQA function?

  • What is the role of clinical project management and regulatory affairs in ensuring FDA compliant sponsor corporate management decisions?

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