Update on EMA & EU payers new initiative: Dialogue to explore synergies, foster mutual understanding & cooperation to improve timely & affordable access to new medicinal products

• The role of regulators in establishing added benefit of novel therapies

• Where do we stand 3 years from kick-off?

• Defining “evidence by design”

• Gaining mutual understanding among all relevant decision-makers on appropriate clinical trial designs, with a view to using the entire spectrum of available methodologies

• What does the EMA & EU payers initiative mean for patients?