09:00-09:05

(5 min)

Jeewon Joung

(AHC)

09:05-09:40

(35 min)

Understanding Clinical Evaluation & Clinical Evidence
 - Importance of Clinical Evaluation & Clinical Evidence in
   the Medical Device Development Process (incl. relevant
   regulations, standards, guidelines, etc.)

Q&A (5 min)

09:40-10:20

(40 min)

IMDRF principles on Clinical Investigation

Q&A (5 min)

10:20-10:50

(30 min)

Clinical Evaluation Planning
 - Define objective, scope and methodology of the
   clinical evaluation
 - How to develop clinical evaluation plan (CEP)
   including evaluation strategy, patient population,
   endpoints, and data collection methods

Q&A (5min)

10:50-11:20

(30 min)

Clinical Evaluation and Clinical Data
- Medical Devices must demonstrate their safety and
  performance through clinical evaluation. IMDRF
  presents the types of clinical data, such as clinical
  investigations, that can be utilized in clinical
  evaluation. This session will discuss the relevancy of
  data and how it can be used in clinical performance

Q&A (5min)

Post-market Vigilance Industry Perspective

Q&A (5min)

09:00-09:30

(30 min)

Regulatory Oversights on Digital Systems & its
application in Medical Device

Q&A (5min)

09:30-10:00

(30 min)

Overview on Digital Health-focused Medical Devices
-    Evolution of its concept, scope, application, its
     benefits & challenges, recent trends, future
     opportunities, etc.

Q&A (5 min)
 

10:00-10:30

(30 min)

Trend in Medical Big Data Standards in Korea

Q&A(5min)

10:30-11:30

(60 min)

Case Studies: Use of Digital Technologies 
 - Case 1 
 - Case 2

Q&A (5 min)

11:30-11:35

(5 min)