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?