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Session 3: Data Standards as a Key to Success
Session Chair(s)
Motohide Nishi, MBA
Japan Site Leader & VP Professional Services
Medidata Solutions K.K., Japan
Yumi Sugiura, MRCP
Global Clinical Operations, Global Data Management and Centralized Monitoring
Bristol-Myers Squibb K.K., Japan
This session covers the status and landscape of data standards in regulatory authorities and pharmaceutical industry with focus on 1) benefit and challenges from experiences, 2) how to address future industry standards, and 3) opportunities for future innovation. This session will also show you how we are going to improve internal/external decision-making using structured scientific data.
Speaker(s)
FDA Perspective on Electronic Submission of Standardized Study Data: Past, Present & Future
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
Pre-Competitive Collaboration in Clinical Trials - TransCelerate Biopharm Inc.
Motohide Nishi, MBA
Medidata Solutions K.K., Japan
Japan Site Leader & VP Professional Services
Data Standardization and Advancing Regulatory Science
Yoshiaki Uyama, PhD, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
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