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S2 - Regulatory Updates and Implications for Clinical Development
Session Chair(s)
Xiaojun (Wendy) Yan, MD, MBA
Strategic Advisor, DIA BOD, China
Jeewon Joung, PHD
Director General, Pharmaceutical and Medical Device Research Dept., NIFDS, MFDS , Korea, Republic of
Speaker(s)
Sarah Ibrahim, PHARMD, PHD
Acting Deputy Center Director for Regulatory Programs, FDA, United States
Massimiliano Sarra, PHD
Pre-Clinical and Clinical Assessor, EMA, Netherlands
Mizukami Maki
Clinical Compliance Inspector, Office of Clinical & Non-clinical Compliance II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Regulatory Updates from PMDA
Xiaoyuan Chen, MD
Professor, Tsinghua University School of Basic Medicine, China
China’s Clinical Trial Infrastructure Landscape from 2015-2025 From Rapid Expansion to Strategic Global Integration
Jooyeon Jung, MPHARM, MS
Division Director, Clinical Trial Dossier Evaluation Division, NIFDS, MFDS, Korea, Republic of
Regulatory Updates from MFDS : Efforts to Innovate IND Review for Early-Stage Oncology Clinical Trials
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