The chance exists to re-align priorities to evaluate the needs of patients, healthcare professionals and health systems to facilitate improved and safer therapies.

There is also space and necessity for enhanced collaboration between EU regulatory and payer groups. This would have the aim of identifying core outcomes other than survival that can be incorporated into trials, as well as healthcare systems, to generate data throughout the lifecycle.

Among others, the conference will pose the following questions:

• How does Europe reconcile rapid access to innovation while incentivising necessary continued research to demonstrating value and societal benefits of new medical products, including IVDs?
• What are the differences that affect regulatory vs payer decisions?
• What specific data elements would allow for efficient assessment of products providing significant benefit to patients?
• Can we find an agreed European (and possibly global) approach to quantifying clinical benefit?
• Are there clinical outcomes other than survival that can be agreed upon to be used in registration trials and healthcare systems?
• Do all low-benefit medications need to be be licensed? 
• How do we best explain the need for both clinical research and ongoing data collection to patients and society and its benefit to both?

The sessions at conference include the following:

• Biomarkers and molecular diagnosis
• Prostate cancer – prevention and early diagnosis
• Orphan regulation and personalised medicine
• Realising the Potential of Data: The Million European Genome Declaration and the EU Digital Health Strategy
• Health literacy and personalised healthcare