2023 AHC Workshop on Medical Device Regulatory Convergence
November 20-21, 2023 | COEX, Seoul, Korea
|
| Date |
Topic |
Speaker |
Video |
Materials |
| Day 1 |
Welcoming Remarks |
Jeewon Joung
(AHC) |
|
|
| Day 1 |
Understanding Clinical Evaluation & Clinical Evidence |
Chang Hyung Lee
(MEDITIP) |
|
|
| Day 1 |
IMDRF principles on Clinical Investigation |
Frances Richmond
(USC) |
|
|
| Day 1 |
Clinical Evaluation Planning |
Cheolho Song
(MFDS) |
|
|
| Day 1 |
Clinical Evaluation and Clinical Data |
You Kyoung Lee
(SCH University) |
|
|
| Day 1 |
Post-market Vigilance Industry Perspective |
Nicole Taylor Smith
(Philips) |
|
|
| Day 2 |
Regulatory Oversights on Digital Systems & its application in Medical Device |
Youngwoo Bae
(MFDS) |
|
|
| Day 2 |
Overview on Digital Health-focused Medical Devices |
Jong Hong Jeon
(ETRI) |
|
|
| Day 2 |
Trend in Medical Big Data Standards in Korea |
Sooyong Shin
(Kakao Health) |
|
|
| Day 2 |
Case Studies: Use of Digital Technologies |
Jaesoon Choi
(LN Robotics) |
|
|
