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Presentations

Preliminary Presentations

Presentation Title

Insourcing versus Outsourcing: Current Trends for IMP Management

  • Compare and contrast the use of internal versus outsourced resources for core aspects of the IMP supply chain (manufacturing, packaging, labeling, distribution).
  • List at least three (3) potential advantages of outsourcing IMP activities.
  • Describe at least two (2) high-volume outsourcing models utilized for IMP activities.

Understanding Regional Differences in IMP GMPs: Focus on US and EU

  • Compare and contrast the QP release process with QA release.
  • Give at least two (2) examples of differences between US and EU GMPs that affect IMP.
  • Explain the impact of non-equivalent GMPs on the QP Declaration process.

Navigating the Challenges of IMP Valuation, VAT and Customs Duties

  • Compare and contrast VAT (Value Added Tax) with sales tax.
  • List at least two (2) criteria used in assessing the value of IMP.
  • Give examples of at least two (2) potential risks or negative outcomes from assigning incorrect valuation to IMP.

The Contracting Process from Start to Finish

  • Describe the contents and purposes of critical contracting documents: Confidentiality Agreement, Master Service Agreement, Scope of Work, Quality Agreement.
  • Explain the potential negative impact to clinical supplies management if the contracting process is given insufficient attention.
  • Summarize the impact of the draft FDA Guidance on Quality Agreements to the contracting process.

Latest Technologies for IMP Labels

  • Give at least two (2) examples of how e-labeling could be used to support investigational materials.
  • Compare and contrast 2D barcodes with standard barcodes.
  • Explain the benefits of innovative labeling technologies to the conduct of clinical trials

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