How Can We Move Towards Harmonization Between Regulatory Bodies to Streamline Global Approval?

Time: 1:05 pm
day: Pre-Conference Workshop Day


Global approval for a gene therapy is something very few drug candidates have achieved, and with many diseases remaining untreated, widening patient access is crucially important. A concerted effort of international collaboration from stakeholders across regulatory authorities and industry is needed to align on safety, efficacy and quality regulations. Regulatory convergence on policies and further clarification of differences in requirements will allow industry to prepare their trial strategy to meet the standards of multiple regions. Thus, harmonization looks to streamline efforts for efficiency, equity and consistency of access while reducing compliance burden for industry. So how can we achieve this?

Come together to be a part of the discussion on:

  • Exploring the similarities and differences in regulatory approach
  • Understanding which countries require further testing to design your trial early for global trial success
  • Identify the bottlenecks to establishing consistency in enrolment rate and approval timelines
  • Strategizing on how to facilitate discussions between different regulatory bodies and industry to streamline regulatory strategy that meets the requirements of various regulatory authorities
  • Harnessing consortia and collaboration to define best practice across product development, trials, manufacturing and quality control
  • Closing the gap between FDA and EMA approvals
  • Exploring international regulatory partnerships as a strategy to streamline approvals