Genome Editing

Genome Editing and Regulatory Harmonization: Progress and Challenges

3:00 PM–4:00 PM Jun 5, 2019 (US - Eastern)

118A, Level 100


Genome editing offers the potential of new and effective treatments for genetic diseases. As companies work to develop these treatments, regulators are focused on ensuring that any such products meet applicable safety and efficacy requirements. This panel will discuss how European Union and United States regulators are approaching therapeutic use of genome editing, issues in harmonization between these two – and other - jurisdictions, challenges faced by industry as regulatory positions evolve, and steps that organizations and companies can take to facilitate approval and continued efforts at harmonization.

Session ID: 504231