Breakout Sessions : Genome Editing and Regulatory Harmonization: Progress and Challenges

jun 5, 2019: 3 p.m. - 4 p.m.
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 %u2013 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.

Speakers

Gary Charbonneau
Senior Vice President ...

Georgia Gavriilidou
Counsel, Food, Drug an...

Emily Marden
Counsel Food Drug and ...

Denise Gavin
Acting Gene Therapy Br...

Daniel Takefman
SVP and Head of Regula...