IMDS School Singapore
Singapore 2023 Agenda
27 - 30 March 2023 GMT+8
Venue: Temasek Polytechnic
Day 1: 27 March 2023
08:00 – 08:30 AM
Registration
08:30 – 09:00 AM
Opening Speech
09:00 – 09:45 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
09:45 – 10:30 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
10:30 – 10:45 AM
Tea Break
10:45 – 11:15 AM
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
11:15 – 11:40 AM
APAC regulatory requirements - South Korea
11:40– 12:00 PM
APAC regulatory requirements - ASEAN, Greater China
12:00 – 13:00 PM
Lunch
13:00 – 13:45 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
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
14:30 – 14:45 PM
Tea Break
14:45 – 15:15 PM
US FDA regulatory requirements
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510(k), PMA and other submissions
15:15 – 16:00 PM
International Medtech Opportunities for Innovation
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Sharing on different type of collaboration opportunities internationally for MedTech companies
16:30 – 17:00 PM
SG Q&A & Quiz (IMDS SG)
17:00 PM
End of IMDS SG Day 1