- Considering other locations and less saturated markets
- Assessing the differences, benefits and challenges of supplying in these regions
- Discussing considerations for supply models, logistics, regulation and importation
- Evaluating important criteria to consider when sourcing CMOs
- Considering steps to take when selecting and managing a CMO in early phase trials
- Reviewing changes and additional factors that become relevant as develop into late phase and commercial
- Identifying opportunities for CDMOs, sponsors, and suppliers using data analytics
- Understanding the clinical trials landscape to facilitate strategic planning
- Addressing issues impacting pharmaceutical supply chains to prepare for and avoid potential disruptions
- Entry screening/admissibility
- FDA regulatory requirements for CBER regulated products
- Making ACE work for you: Importing biological products
- Q&A session
- Close-out
- Identifying logistical challenges and how to overcome them
- Understanding and complying with regulatory requirements
- Mitigating against cold chain risks
