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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe


[S39] Utilization of RWD for the Clinical Trial Design and New Drug Application

Session Chair(s)

Takashi  Moriya, PhD, MBA

Takashi Moriya, PhD, MBA

  • Director
  • Janssen Pharmaceutical K.K., Japan
Regulators, industries, and academia have been very interested in how to use Real World Data (RWD) in clinical development. This session will introduce approaches to conducting effective clinical trials using RWD and/or Electronic Health Records (EHRs), and share common current efforts to resolve problems that presently remain for more efficient use of RWD. Database research using RWDs is also actively being considered in Japan. This session will also introduce new clinical trial models in Japan from the viewpoints of industry, government, and academia.

Speaker(s)

Takeharu  Yamanaka, PhD

Can We Use RWD for Regulatory Decision in Oncology Drug Development?

Takeharu Yamanaka, PhD

  • Professor, Department of Biostatics, School of Medicine
  • Yokohama City University, Japan
Tammy  Guld, MS

Connected And Enriched Health Data To Optimize Clinical Research Across The Drug Development Cycle

Tammy Guld, MS

  • Clinical Innovation Global Team Lead
  • Janssen Pharmaceuticals, United States
Kinue  Nishioka, PhD

PMDA’s Activities for Regulatory Utilization of Real World Data

Kinue Nishioka, PhD

  • Review Director, Office of Advanced Evaluation with Electronic Data
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan