Workshop B – Building SOPs, Governance Structures & Internal Alignment for New Expanded Access Teams

• Defining ownership across Medical, Regulatory, Clinical Operations and Supply
• Determining which clinical trial processes should be adapted for EAPs
• Building governance structures and approval workflows
• Securing internal buy-in and managing cross-functional stakeholders

Speakers:

Tania Azad

Global Program Director, Late Phase Clinical Operations

Alexion Pharmaceuticals

Damian Inlall

Senior Associate Director, Medicine Capability Excellence Owner

Boehringer Ingelheim

Eleana Hardy

Head, Global Independent Medical Education, Investigator Sponsored Trials, & US Expanded Access Program

Jazz Pharmaceuticals