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S39 : Assessing Real-World Data Relevance and Reliability for Regulatory Submission Across Stakeholder Views
Session Chair(s)
Mitsune Yamaguchi, PhD
Director, Office of Non Clinical and Clinical Compliance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s)
Hideaki Bando
Head physician, National Cancer Center Hospital East, Japan
Kazuyoshi Takeda
Head, Department of Clinical Research Planning and Analysis, National Center of Neurology and Psychiatry (NCNP), Japan
Ryosuke Annaka
Head of Health Data Policy Group, Innovation Promotion Subcommittee, Japan Pharmaceutical Manufacturers Association (JPMA), Japan
Miho Suzuki
, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Hideharu Yamamoto, PhD
Chairperson Data Science Expert Committee Drug Evaluation Committee, Chugai Pharmaceutical Co., Ltd., Japan
YOSUKE NISHIDA
MANAGER, Pwc Consulting, Japan
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