- Entry screening/admissibility
- FDA regulatory requirements for CBER regulated products
- Making ACE work for you: Importing biological products
- Q&A session
- Close-out
Archives: Agenda
Ensuring end to end cold chain integrity
- Identifying logistical challenges and how to overcome them
- Understanding and complying with regulatory requirements
- Mitigating against cold chain risks
Registration and refreshments
Morning refreshments and networking
Chairperson’s opening remarks
Panel Discussion: Improving communications between clinical supply, clinical operations and their partners
• 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
Navigating multiple regulatory agencies to help expedite supply chain times
- 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
Global virtual clinical trial supplies: The benefits of implementing a virtual supply strategy for commercially available medications and ancillary supplies
- Optimize employ effort
- Minimize waste and risk
- Appreciate significant savings
- Sustainably friendly
Chairperson’s closing remarks
Fireside Chat: The power of the Pharmacy Manual and IRT management as vital tools for improving clinical supply operations
- 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