Strategizing to Gain EMA Regulatory Approval & Aligning Regulatory and Payer Expectations

Time: 9:05 am
day: Pre-Conference Workshop Day


The European market is a notoriously tricky area to navigate for gene therapy products, and there is a significant disconnect between what regulators require for a product to gain approval, and what payers require from a product.

This workshop will provide a discussion-based deep-dive into the best strategies to build adequately robust data packages for European regulatory approval, and how to please payers to help save time and money in developing gene therapies for neurological disorders.

This session will include:

  • Hearing about the requirements to gain regulatory approval in Europe for gene therapies for neurological disorders
  • Discussing how to best prove efficacy and safety to please payers in Europe
  • Debating how to better align the data requirements for regulatory approval and payer expectations for neurological gene therapies