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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
Senior Reviewer, Cardiovascular & Neurology Products Division/MFDS, Ministry of Food and Drug Safety, Korea, Republic of
Using RWD/RWE in the Life Cycle of a Drug – Case Study - Japan
Bruce Crawford, MA
Vice President, Real-World Evidence and Insights, Japan and APAC, Syneos Health, Japan
Using RWD/RWE in the Life Cycle of a Drug - Case Study – China
Xun LIU
Head of Medical & Regulatory Affairs, Sandoz, China
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