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