Clinical Quality Assurance and Management Policy: Two Case Histories
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:
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What corporate decisions occurred?
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Why did one site close down in response to the FDA enforcement action?
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Why does corporate management not share the clinical research or the regulatory perspective?
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What is the required corporate management CQA interface?
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Where and why did it fail?
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FDA sponsor obligations - what are they?
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What is the sponsor's liability and exposure for FDA enforcement action?
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How do the concepts of misconduct, fraud, and sponsor due diligence impact the FDA application of enforcement actions?
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How can CQA enable corporate management to empower the CQA function?
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What is the role of clinical project management and regulatory affairs in ensuring FDA compliant sponsor corporate management decisions?