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Virtual

Sep 07, 2021 8:45 AM - Sep 07, 2021 5:00 PM

(Singapore Standard Time)

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

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)

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 Arnold Chan, DrSc, MD, FISPE

Perspective from Academia: Kinwei Arnold Chan, DrSc, MD, FISPE

Senior Vice President, Insight and Evidence Generation

TriNetX, LLC, United States

Gorana  Capkun-Niggli

Perspective from Industry: Gorana Capkun-Niggli

Global Head RWE

Novartis Oncology, Switzerland

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