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IMDS School Singapore
Singapore 2024 Agenda
18 - 21 March 2024 GMT+8
Venue: Temasek Polytechnic
Day 1: 18 March 2024
08:00 – 08:30 AM
Registration
08:30 – 09:00 AM
Opening & Welcome Remarks
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
EU & US Regulatory Requirements
10:30 – 10:45 AM
Tea Break
10:45 – 11:15 AM
Global Regulatory Strategy
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
Clinical Trial for Innovation Products
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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
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
The trends of Medical Device Industry in Korea
15:15 – 16:00 PM
KMDIA Session
16:30 – 17:00 PM
SG Q&A & Quiz (IMDS SG)
17:00 PM
End of IMDS SG Day 1