Best practice for clinical evaluation, practical scientific approach for data generated through a literature review of IMDRF N56
You Kyoung Lee ┃ Soonchunhyang University
About the Speaker
You Kyoung Lee
APEC Medical Device CoE
Director and Professor
Republic of Korea
A brief history
Dr. Lee is currently working at Soonchunhyang University Hospital as a clinical pathologist and professor. She has over 25 years of experience in the clinical laboratory, including a 15-year director position. Her main interests are Evidence-based Medicine (EBM) and Quality Medicine. In this aspect, she published articles and book chapters relating to a pragmatic evidence synthesis between quality and downstream effects in the laboratory or clinical practices.
She extends her research field to the medical device vigilance (MDV) from 2013. Now she carries her role as a director of the APEC Regulatory Training Center of Excellence Soonchunhyang University. She is one of the active researchers of the MDV field in Korea.
She now actively contributes as an expert for interdisciplinary cooperation between professional medical societies and engineering societies as a Board Member of the Korean Academy of Medical Sciences (KAMS) and the Member of Regulatory Innovation Committee under the Prime Minister's Office of Korea.