2023 Fellows Courses

Dr. Petit (New York-Presbyterian), Dr. Zablah (Children’s Hospital Colorado), and Ms. Lee (Director of Regulatory Affairs-Occlutech USA) will discuss the historical interactions with regulatory bodies in the United States and Europe, current programs to reduce regulatory burden like Harmonizing by Doing and how the regulatory environment directly affects congenital heart disease practitioners.  Dr. Petit and Dr. Zablah will share their experiences as researchers, how they engaged with the FDA reviewers from an early point in their careers– and how this has served their patients.  Christine will share insights into how industry and physicians can collaborate to educate regulatory bodies on patient needs.