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IMDS School Singapore
Singapore 2024 Agenda
18 - 21 March 2024 GMT+8
Venue: Temasek Polytechnic
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Day 1: 18 March 2024
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08:00 – 08:15 AM
Registration
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08:15 – 08:30 AM
Opening & Welcome Remarks
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08:30 – 09:15 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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09:15 – 09:40 AM
EU Regulatory Requirements & Strategy​
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Brief Overview of Regulation & Strategy
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Case studies
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09:40 – 10:05 AM
US Regulatory Requirements & Strategy​
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Brief Overview of Regulation & Strategy
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Case studies
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10:05 – 10:30 AM
Innovation vs Regulation: Friend or Foe?
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10:30 – 10:45 AM
Tea Break
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10:45 – 11:15 AM
Medical software – Regulation & Strategy​
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11:15 – 11:40 AM
Use of Real-World Evidence for regulatory approval in Korea
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11:40– 12:00 PM
Medical Device reimbursement in Korea – A MedTech company’s worst nightmare?
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12:00 – 13:00 PM
Lunch
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13:00 – 13:45 PM
Clinical Investigation for the registration of Medical Devices in Korea
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13:45 – 14:30 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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14:30 – 14:45 PM
Tea Break
14:45 – 15:15 PM
MedTech in Korea – Where is it heading?​​
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15:15 – 15:45 PM
The Startup Journey – From Concept to Commercialization and Adoption​​
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15:45 – 16:15 PM
Startup Funding – Tips for landing it
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16:15 PM
End of IMDS SG Day 1
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