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[V3-S1] The Dawn of Advanced Regulatory Review and Consultation
Session Chair(s)
Motohide Nishi, MBA
Japan Site Leader & VP Professional Services
Medidata Solutions K.K., Japan
Speaker(s)
Future Plans for Advanced Review with Electronic Data in Japan
Mayumi Shikano, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Center Director (for Advanced Review with Electronic Data Promotion)
From FDA's Perspective
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
The Dawn of Advanced Regulatory Review and Consultation-From Industry’s Perspective -
Hironobu Saito, PhD
Tottori University, Chromosome Egineering Research Center, Japan
Specially Appointed Professor
CDISC Global Data Standards
Bron Kisler
Nurocor, United States
Senior Vice President Customer Alliances and Partnerships
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