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