Back to Agenda
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
Chief Executive Director, NISHIUMA CO., LTD., 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)
Takahiro Nonaka, PHD
Head of Epidemiology, Medical information Division, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Kinwei Arnold Chan, DRSC, MD, FISPE
Senior Vice President, Insight and Evidence Generation, TriNetX, LLC, United States
Gorana Capkun-Niggli
Global Head RWE, Novartis Oncology, Switzerland
Have an account?