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Session 4: Townhall PMDA & MFDS- Using RWD/RWE in the Life Cycle of a Drug - Japan, Korea
Session Chair(s)
Sora Lee, MBA, MPharm, RPh
Vice President, General Manager Korea
Syneos Health Inc., 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)
Using RWD/RWE in the Life Cycle of a Drug - Japan
Shun Tezuka
PMDA, Japan
System Maintenance for RWD/RWE Based on Evidence and Case Study in Korea
Wonim Do
Ministry of Food and Drug Safety, Korea, Republic of
Senior Reviewer, Cardiovascular & Neurology Products Division/MFDS
Using RWD/RWE in the Life Cycle of a Drug – Case Study - Japan
Bruce Crawford, MA
Syneos Health, Japan
Vice President, Real-World Evidence and Insights, Japan and APAC
Using RWD/RWE in the Life Cycle of a Drug - Case Study – China
Xun LIU
Sandoz, China
Head of Medical & Regulatory Affairs