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DIA Asia 2021-The Evolution Of Clinical Trials And Regulatory Science In A Post-Pandemic Digital World In Asia

The timing is as per Singapore Time Zone


Session 2: RWE

Session Chair(s)

Kum Cheun  Wong, PharmD

Kum Cheun Wong, PharmD

  • Head Asia Pacific Regulatory & Development Policy
  • Novartis Asia Pacific Pharmaceuticals Pte. Ltd., Singapore
Shinichi  Nishiuma, MD

Shinichi Nishiuma, MD

  • Head of Oncology Medical Science, Japan medical
  • Bristol-Myers Squibb K.K., 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

RWE for regulatory decision-JP perspective (Focus on disease registry)

Takahiro Nonaka, PhD

  • Head of Epidemiology, Medical information Division
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Kinwei  Chan, DrSc, MD, FISPE

Perspective from Academia

Kinwei Chan, DrSc, MD, FISPE

  • Director, Clinical Trial Center
  • National Taiwan University Hospital, Taiwan
Gorana  Capkun-Niggli

Perspective from Industry

Gorana Capkun-Niggli

  • Global Head RWE
  • Novartis Oncology, Switzerland

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