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IMDS School Singapore
Korea 2023 Agenda
27 March 2023
Venue: Korea
Day 1: 27 March 2023 (KST )
09:00 – 09:30 AM
Registration
09:30 – 10:00 AM
Opening Speech
10:00 – 10:45 AM
The role of Industry Associations and partners in regulatory convergence and healthcare innovation
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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
10:45 – 11:30 AM
Clinical trial for Innovation in Asia
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What are funding available and criteria
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Single or Multi-centre trial
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Plan and conduct of Clinical trial
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Differences between Clinical trial vs clinical evaluation
11:30 – 11:45 AM
Tea Break
11:45 – 12:15 PM
Medtech Manufacturing Set-up or Contract manufacturing Outsourcing?
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Benefit and key considerations in set-up manufacturing or outsource
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Contract manufacturing vendor selection criteria
12:15 – 12:40 PM
APAC regulatory requirements - South Korea
12:40– 13:00 PM
APAC regulatory requirements - ASEAN, Greater China
13:00 – 14:00 PM
Lunch
14:00 – 14:45 PM
MDR & IVDR CE mark regulatory requirements – Introduction & Conformity assessment Routes
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MDD and the New MDR, Other related Directives e.g., Combination products
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Conformity assessment routes for CE Marking
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Post Market: Vigilance, PMCF, PSUR
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Further changes e.g., Eudamed, Clinical Evaluation
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IVDD and the New IVDR
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Conformity assessment routes for CE Marking
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Post Market: Vigilance, PMPF, PSUR
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Further changes in EU e.g., Companion diagnostic
14:45 - 15:00 PM
Korea Q&A (End of IMDS KR)