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Keynote Speech (B)
Session Chair(s)
Motohide Nishi, MBA
Japan Site Leader & VP Professional Services
Medidata Solutions K.K., Japan
Mika Ogasawara
Data Quality Lead, Biometrics and Data Management
Pfizer R&D Japan G.K., Japan
Speaker(s)
Keynote Speech 3: Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
Keynote Speech 4: An Update on Data Standards at FDA's Center for Drug Evaluation and Research (CDER): A Statistical Review Perspective
Steve Wilson, PhD
FDA, United States
Senior Staff Fellow, OB, OTS, CDER
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