Cultivating a Global Perspective on Regulation to Unveil the Similarities & Differences in Regulation Across the World to Simplify Application Processes in Regions Outside the USA

Time: 8:02 am
day: Pre-Conference Workshop Day

Details:

With many companies preparing for global expansion of their cell and gene therapies, clarity in regulation across the USA, Europe, UK, Australia, Canada, Japan, and South America is paramount to this journey. Whilst there is much similarity between regulatory body requirements, this session aims to highlight key differences to foster understanding and provide solutions to challenges.

Join this session to:

  • Explore Europe’s CTR processes to address challenges specific to cell and gene therapies in comparison to general biologics
  • Unpack the intricacies of genetically modified organism (GMO) classification in this region to streamline documentation processes
  • Compare regulations from a global perspective and review convergence among different regions

Speakers: