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Keynote Speech
Session Chair(s)
Mika Ogasawara
Data Quality Lead, Biometrics and Data Management
Pfizer R&D Japan G.K., Japan
Motohide Nishi, MBA
Japan Site Leader & VP Professional Services
Medidata Solutions K.K., Japan
Keynote Speach
Speaker(s)
KEYNOTE SPEACH 1: Drug Access and Affordable Cancer Care in Japan
Yasuhiro Fujiwara, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Chief Executive
KEYNOTE SPEACH 2: PMDA’s Initiative for Promotion of Regulatory Science
Mayumi Shikano, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Center Director (for Advanced Review with Electronic Data Promotion)
KEYNOTE SPEACH 3: FDA Strategy - Leveraging Electronic Standards to Expand Data Usability
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
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