Archives: Agenda

• Understanding the requirement and options for declaring biological materials to U.S. Customs and Border Protection (CBP)
• Review of key U.S. regulatory agency authorities, such as CDC, FDA, USDA, and CBP
• Discovering the latest non-compliant shipment issues for biological materials and pharma products and tips to avoid them
• Learning about valuable resources and contacts for assistance

• Interacting earlier for supply to give input and gain information sooner so they can assist and be prepared
• Establishing clinical team needs: what, when and where
• Building and maintaining strong relationships between teams

• Optimize employ effort
• Minimize waste and risk
• Appreciate significant savings
• Sustainably friendly

• Deciding your strategy: in advance, just in time or hybrid?
• Considering regulatory packing & labelling requirements for the locations of your study supply
• Identifying the best packaging and labelling solution to accelerate your drug supply
• Improving expiry date challenges to avoid re-labelling or wastage

• IRT and Pharmacy Manual alignment
  • How both tools are connected
  • Challenges and ways of working
• IRT and the Pharmacy Manual as useful tools for Clinical Operations engagement
  • Examples of each and how it’s driven engagement and alignment with Clinical Operations

• Transforming anecdotal stakeholder feedback into impactful data to drive performance discussions
• Identifying meaningful metrics and indicators to include in the scorecard
• Automating metric data collection for incorporation into a scorecard
• Lessons learned in implementing the scorecard successfully