APEC Harmonization Center Workshop:
Post-Pandemic Regulatory Environment Changes in Clinical Trials
| No | Speakers Information | |
|---|---|---|
| 1 | Jeewon Joung |
Team Leader AHC(APEC Harmonization Center); Director Pre-Submission Consultation Team, Innovative Products Development Support Department; |
|
Day 1 · Welcoming Remarks |
||
| 2 | Sumitra Sachidanandan |
Regulatory Consultant Innovation Office & Clinical Trials Branch, Health Products Regulation Group Health Sciences Authority (HSA), Singapore |
|
Day 1 >Session 1 · Setting the Scene: COVID-19 Pandemic’s impact in global regulatory environment; |
||
| 3 | Yvanka Gilliam |
Head Clinical Alliance Singapore Clinical Research Institute(SCRI), Singapore |
|
Day 1 >Session 2 · Deep Dive into Decentralized Clinical Trials (DCTs) |
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| 4 | Yi-Hsuan Hsu |
Associate Reviewer Department of Clincial Trials, Division of Medicinal Products TFDA(Taiwan Food and Drug Administration), Chinese Taipei |
|
Day 1 >Session 2 · Current Regulatory Landscape for DCTs |
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| 5 | Jiyeon Park |
Medical Doctor Department of Clincial Pharmacology and Therapeutics Seoul National University(SNU) College of Medicine and Hospital, Korea |
|
Day 1 >Session 2 · Practitioner perspectives on DCTs |
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| 6 | Lilith Hayakawa Mist |
Executive Director Global Clinical Trial Operations Merck, United States |
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Day 2 >Session 2 · Quality Risk Management for DCTs |
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| 7 | Aparajeeta Priyadarasini |
Leader Soultion Consulting for AP South, India and Korea Medidata Dassault Systems, Singapore |
|
Day 2>Session 2 · Data Management and Analysis in DCTs |
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| 8 | Kwunho Jeong |
CEO(Chief Executive Officer) JNP MEDI, Korea |
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Day 2>Session 2 · Future of DCTs: Regulatory Opportunities & Challenges |
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| 9 | Eun Young Park |
Chief Executive Officer(CEO) AinB, Korea |
|
Day 2>Session 3 · Application of AI in Drug Development |
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