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Session 5: Townhall FDA & EMA - RWE/RWD Regulatory Update and Case Study
Session Chair(s)
Choon K. Oh
CTO & Executive Vice President
Chong Kun Dang Pharmaceutical Corp, Korea, Republic of
The evolving landscape of Real World Data (RWD) and the use of machine learning & analytics platforms to generate Real World Evidence (RWE) are becoming important for regulatory decision-making. Learn how FDA, EMA, PMDA, and MFDS regulators’ current uses of RWE/RWD and how they can be applied for other applications. Recognize general considerations and key features of successful RWE studies acceptable to the regulators for effective decision-making. Gain deeper insights with case studies and live examples of utilizing RWD/RWE at the major stages of the drug life cycle shared by industry speakers.
Speaker(s)
Leveraging Real-World Data/Evidence in Regulatory Science
Tae Hyun Jung, PhD
FDA, United States
Senior Statistical Reviewer, CDER
Using RWD/RWE in the Life Cycle of a Drug - EU
Kelly Plueschke
European Medicines Agency, Netherlands
Principal Scientific Administrator, Data Analytics and Methods Task Force
Using RWD/RWE in the Life Cycle of a Drug - Case Study
Jeff Lange, PhD
Amgen, Hong Kong
Director of Observational Research in Asia