Global Regulatory Update

Guest Editor: Dr Paula Salmikangas, NDA

As global regulatory agencies continue to evolve their policies to match the pace of development in cell and gene therapy, it’s essential for both academic and commercial scientists to understand the implications of these changes on their path to translation and product commercialization. This Spotlight provides the latest updates on:

  • The impact of Japan’s innovative approach to regulating cell therapies and regenerative medicines not only within Japan but for international companies looking to collaborate/partner and take advantage of this regulatory environment.
  • Recent success stories of commercial leaders in navigating their cell and gene therapy products through the regulatory landscape.
  • Post-Brexit regulatory structure in the UK and what this means for your product.
  • How the various regulatory agencies – FDA, EMA – are working to keep pace with this rapidly advancing field.
    • Coming soon in July 2018