Bridging the Gap Between Regulatory Approval & Commercial Launch: Access Strategies

  • What are the important characteristics of early access in Europe, including what makes it complicated and whether it could become easier
  • What are the key practical perspectives of EU early access to be aware of, particularly after centralized Marketing Authorization
  • What does EU early access look like in small biotech, and how can the transition of an early access program from biotech to pharma be supported