.png)
IMDS School Korea
Korea 2024 Agenda
18 March 2024
Venue: 9F, Korea University Medicine Koyoung campus, 413, Dosan-dearo, Gangnam-gu, Seoul, Republic of Korea
Day 1: 18 March 2024 (KST)
09:00 – 09:15 AM
Registration
09:15 – 09:30 AM
Opening & Welcome Remarks
09:30 – 10:15 AM
Role of Trade Associations – Driving access, innovation & collaboration
-
The effective network of industry associations across the ASEAN, ASIA, EU, US, GLOBAL
-
The importance of association’s role for its stakeholders i.e. local industry and the national authorities/agencies
10:15 – 10:40 AM
EU Regulatory Requirements & Strategy
• Brief Overview of Regulation & Strategy
• Case studies
10:40 – 11:05 AM
US Regulatory Requirements & Strategy
• Brief Overview of Regulation & Strategy
• Case studies
11:05 – 11:30 AM
Innovation vs Regulation: Friend or foe?
11:30 – 11:45 AM
Tea Break
11:45 – 12:15 PM
Medical software – Regulation & Strategy
12:15 – 12:40 PM
Use of Real-World Evidence for regulatory approval in Korea
12:40 – 13:00 PM
Medical Device reimbursement in Korea – A MedTech company’s worst nightmare?
13:00 - 14:00 PM
Lunch
14:00 - 14:45 PM
Clinical Investigation for the Registration of Medical Devices in Korea.
14:45 - 15:30 PM
Global Harmonization of the medical device regulations
-
Overall regulations, directives, guidelines IMDRF, AHWP, ASEAN MDD, EU, US, Canada, Japan, Australia·
-
· Definition and Risk classification of Medical Device, IVD, and Combination product
15:30 - 15:45 PM
Tea Break
15:45 - 16:15 PM
MedTech in Korea – Where is it heading?
16:15 - 16:45 PM
The Startup Journey – From Concept to Commercialization and Adoption
16:45 - 17:15 PM
Startup Funding – Tips for landing it
17:15 PM
(End of IMDS KR)