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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

  • The effective network of industry associations across the ASEAN, ASIA, EU, US, GLOBAL

  • 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

  • What are funding available and criteria

  • Single or Multi-centre trial

  • Plan and conduct of Clinical Trial

  • Differences between Clinical Trial vs Clinical Evaluation

13:45 – 14:30 PM

Global Harmonization of the medical device regulations

  • Overall regulations, directives, guidelines IMDRF, AHWP, ASEAN MDD, EU, US, Canada, Japan, Australia

  • 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

Topics and Speakers are subjected to change

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