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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
FDA, United States
Acting Deputy Center Director for Regulatory Programs
Massimiliano Sarra, PHD
EMA, Netherlands
Pre-Clinical and Clinical Assessor
Regulatory Updates from PMDA
Mizukami Maki
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Clinical Compliance Inspector, Office of Clinical & Non-clinical Compliance II
China’s Clinical Trial Infrastructure Landscape from 2015-2025 From Rapid Expansion to Strategic Global Integration
Xiaoyuan Chen, MD
Tsinghua University School of Basic Medicine, China
Professor
Regulatory Updates from MFDS : Efforts to Innovate IND Review for Early-Stage Oncology Clinical Trials
Jooyeon Jung, MPHARM, MS
NIFDS, MFDS, Korea, Republic of
Division Director, Clinical Trial Dossier Evaluation Division