APEC Harmonization Center Medical Device Regulatory Convergence Workshop
| No | Speakers Information | |
|---|---|---|
| 1 | Jeewon Joung |
Team Leader AHC(APEC Harmonization Center); Director Pre-submission Consultation Division in Innovative Products Development Support Department |
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Day 1 · Welcoming and Opening Remarks |
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| 2 | Chang Hyung Lee |
Chief Advisior MEDITIP, Korea |
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Day 1>Session 1 · Understanding Clinical Evaluation & Clinical Evidence |
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| 3 | Frances Richmond |
Professor Emerita USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences University of Southern California (USC), United States |
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Day 1>Session 1 · IMDRF principles on Clinical Investigation |
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| 4 | Cheolho Song |
Reviewer Pre-submission Consultation Division MFDS(Ministry of Food and Drug Safety), Korea |
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Day 1>Session 1 · Clinical Evaluation Planning |
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| 5 | You Kyoung Lee |
Professor Soonchunhyang University Bucheon Hospital; Director Soonchunhyang University Medical Device Clinical Research Center (MDCR), Korea |
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Day 1>Session 1 · Clinical Evaluation and Clinical Data |
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| 6 | Nicole Taylor Smith |
Vice President Global Head of Regulatory Science and Policy Philips, United States |
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Day 1>Session 1 · Post-market Vigilance Industry Perspective |
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| 7 | Youngwoo Bae |
Asistant Director Digital Health Devices Division, Department of Medical Device Evaluation MFDS(Ministry of Food and Drug Safety), Korea |
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Day 2>Session 2 · Regulatory Oversights on Digital Systems & its application in Medical Device |
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| 8 | Jong Hong Jeon |
Principle Member of Research Staff Standard & Open Source Research Division Electronics and Telecommunications Research Institute (ETRI), Korea |
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Day 2>Session 2 · Overview on Digital Health-focused Medical Devices |
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| 9 | Soo-Yong Shin |
Head of Research and Chief Privacy Officer Kakao Healthcare, Korea |
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Day 2>Session 2 · Trend in Medical Big Data Standards in Korea |
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| 10 | Jaejun Yim |
Head Management Planning Division VUNO, Korea |
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Day 2>Session 2 · Case Studies: Use of Digital Technologies |
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| 11 | Jaesoon Choi |
CEO(Chief Executive Officer) LN Robotics; Professor Department of Biomedical Engineering, University of Ulsan College of Medicine; Director Biodemidcal Engineering Research Center Asan Medical Center, Korea |
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Day 2>Session 2 · Case Studies: Use of Digital Technologies |
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