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Analyzing the Complexities of IVD Clinical Sample Regulation in US Trials



 
Our Price: $395.00

Product Code: WB-7005
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Product Info
 
About the Product
Includes 1 hour and 40 minute Windows Media Video File and PowerPoint presentations for immediate download.

Clinical patient samples play a key role throughout the IVD development process, which can often take several years before obtaining market approval. Clinicians have been tasked with a growing demand for clinical patient samples with more precise patient information and are responsible for ensuring they have retained all the relevant clinical information to meet evidence based medicine requirements. This can be difficult, as many readily available samples are left over from hospital tests, lacking the necessary patient information. Prior to the selection of a clinical sample, it is critical for clinicians to clearly define the sample's individual requirements including factors such as the number of samples, patient information and evidence of patient consent. Many have forecasted an enhanced pre- and post-market regulatory framework, which will likely affect the resources IVD manufacturers will have to dedicate to sourcing clinical patient samples.
  • Mapping sample necessities and considerations throughout IVD development and post-approval
  • Key considerations when determining appropriate sample population
    • Ensuring samples accurately representative intended use population
    • Weighing quantity and quality considerations
  • Outlining primary factors in determining appropriate sample size
  • Selecting/sourcing the most appropriate sample supplier
  • Methods for assuring IRB approval is achieved
    • Implementing procedures for ethical sample collection
    • Understanding manufacturer liabilities
  • Sample requirements for IVDs targeting novel therapies/biomarkers

Speaker:

Robert Parson
Vice President, Regulatory and Clinical Affairs
Hologic


Target Audience

  • Clinical Affairs/Research
  • Clinical Trial Manager
  • Regulatory Affairs
  • Quality Assurance

Target Industry
  • Diagnostic Manufacturers

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