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Session 6 - CDISC and Electronic Data Submission
Session Chair(s)
Yukiko Nagata
Director, Biometrics
ICON Clinical Research GK, Japan
Toshiki Sugita, PhD
Office of Review Management, Review Management Division
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Both health authorities, PMDA and FDA, will require electronic data submission using CDISC Data Standards in future submission. Pharmaceutical companies would need to create internal process to adjust to this big change. The goal of this session is to discuss new requirements and successful global electronic data submissions. Additionally, Rebecca D. Kush, PhD, President, CDISC is invited and she shares with us about details of CDISC Therapeutic Area Data Standards initiative to Streamline Clinical Research.
Speaker(s)
One Global Electronic Data Submission
Yuichi Nakajima
Novartis Pharma K.K., Japan
Head, Statistical Programming Strategy & Operations.
Coalition For Accelerating Standards and Therapies: Innovative Partnership for Developing CDISC Therapeutic Area Data Standards to Streamline Clinical
Rebecca Daniels Kush, PhD
Elligo Health Research, United States
President, Catalysis; Chief Scientific Officer
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