Archives: Agenda
Registration and refreshments
Outsourcing the Work, Not the Accountability: A Practical Framework for Oversight in FSP Oncology Trials
• Why FSP changes oversight: where control, accountability and risk shift
• Designing oversight: clear layers, decision rights and risk-based measures
• Turning findings into action: evidence, proportionate escalation and a closed loop
Outsourcing the Work, Not the Accountability: A Practical Framework for Oversight in FSP Oncology Trials
• Why FSP changes oversight: where control, accountability and risk shift
• Designing oversight: clear layers, decision rights and risk-based measures
• Turning findings into action: evidence, proportionate escalation and a closed loop
PANEL DISCUSSION The Feasibility Balancing Act: Are Sponsors Pushing Sites Beyond Capacity?
- Why recruitment forecasts and feasibility assessments across the DACH region continue to miss targets despite strong research infrastructure and healthcare systems
- How increasing study competition, protocol complexity, and limited patient availability are placing growing pressure on sites
- The operational challenges impacting recruitment and patient access across the region
- How sponsors, CROs, and sites can work together to create more realistic feasibility strategies and more sustainable approaches to patient recruitment and site engagement
Moderator: Karen Cheng, Patient Advocate, The Myositis Association (TMA)
PRIZE DRAW
Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!
Biosimilar Development: New FDA and EMA Regulations Are a Paradigm Shift After 20 Years of Biosimilars
- Reducing development costs through leaner clinical strategies
- Navigating evolving regulatory expectations for biosimilars in Europe and globally
- Understanding how outsourcing models differ for biosimilar programs versus innovative therapies