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Session 2: RWE
Session Chair(s)
Kum Cheun Wong, PharmD
Head Asia Pacific Regulatory & Development Policy
Novartis Asia Pacific Pharmaceuticals Pte. Ltd., Singapore
Shinichi Nishiuma, MD
Executive officer, Chief Medical Officer
Aculys Pharma Inc,, Japan
Real World Evidence (RWE) is changing the landscape of drug development, clinical trials and regulatory decision-making process, touching the entire chain of healthcare. It is beginning to transform the direction from the historical use for post-marketing safety monitoring to adoption to support clinical trial design and studies to generate better treatment outcomes. This session will look into the current regulatory landscape and possibilities of RWE in transforming drug development, regulatory decision in achieving better outcomes for patients
Speaker(s)
RWE for regulatory decision-JP perspective (Focus on disease registry)
Takahiro Nonaka, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Head of Epidemiology, Medical information Division
Perspective from Academia
Kinwei Arnold Chan, DrSc, MD, FISPE
TriNetX, LLC, United States
Senior Vice President, Insight and Evidence Generation
Perspective from Industry
Gorana Capkun-Niggli
Novartis Oncology, Switzerland
Global Head RWE