Thank you for attending the Virtual 2020 Japan Interchange. You will find a link to each of the presentation slides from the event below.
Note: Presentations are subject to copyright and may not be used without written consent of CDISC or its affiliates.
CDISC Pre-Conference Presentations
Attendees of this event received access to the following pre-conference CDISC presentations:
- CDISC 360: The Journey So Far and the Road Ahead, by speakers from CDISC, Microsoft Clinical Research Innovation Hub, Novo Nordisk A/S, XClinical, Vita Data Sciences, Allergan, and AstraZeneca
- CDISC RWD Connect, by Rhonda Facile, CDISC VP, Development Opportunities
- CDISC Library Update: Standards Browser Overview, by Mike Hamidi, CDISC Head of Data Science
- A New Training Frontier: CDISC Blended Learning, by Saad Yousef, CDISC Senior Manager, Education Operations
- Modeling Genetics/Genomics Data in SDTM: An Update from CDISC, by Jon Neville, CDISC Senior Standards Developer
Virtual CDISC Japan Interchange - Day 1
Welcome Address & State of the CDISC Union
David R. Bobbitt, CDISC President and CEO
PMDA Keynote Address
Dr. Yasuhiro Fujiwara, Chief Executive, PMDA
State of CDISC Standards & COVID-19 Interim User Guide
Bess LeRoy, CDISC
PMDA Update
Dr. Yuki Ando, PMDA
Machine Learning for Understanding CDISC/FDA Documents and Clinical Trial Data
Dr. Wenjun Bao, JMP Life Sciences, CDISC Board of Directors
Simplifying the Integration Riddle
Mai Ishikawa, Divya P and Amara Bharathy, Zifo RnD Solutions
Introduction of A New Concept: Analysis Results Data Model (ARDM)
Stanley Wei, Novartis
Implementing Study Data Tabulation Model (SDTM) in RECIST/iRECIST Data of Multinational Clinical Trial: Central Imaging Core Lab
Jung Hyun Lee, Clinical Trial Center at Asan Medical Center
CDISC Implementation in JPMA Companies: Behind the Scenes
Naoto Awaji, Chugai
CDISC Standards with Python and Data Pipelines
Denislav Ganchev, Biodome Clinical Ltd.
Development of a SEND Data Model and Accompanying QC Checks
Gitte Frausing, Data Standards Decisions Aps
HMA - EMA Joint Big Data Task Force: Evolving Data Driven Regulation
Sofia Zastavnik, EMA
Virtual CDISC Japan Interchange - Day 2
Helpful Tips for Review-Ready NDA/BLA Submissions to FDA CDER
Dr. Matilde Kam, FDA-CDER
Collaboration and A Public Health Crisis
Helena Sviglin, FDA-CDER
Assessing Liver Toxicity: Approach & Tools
Dr. Alan Shapiro, FDA-CDER
Using SEND Data Sets to Enable Large-Scale Data Analytic Approaches for Preclinical Toxicology Data
William Houser, Bristol Myers Squibb / Biocelerate
Standardization and Continuous Improvement of eData Submission Process
Nao Makino, EPS Corporation, JCROA
SDTM Review, Practice and Challenge
Minoru Mizutome, UCB Japan
SDTM Datasets Made from Ongoing Study Data for J-NDA
Keiichiro Sakuraba, CDISC Japan User Group SDTM Team
Handling Re-Screening Subjects in SDTM Data
Arvind Sri Krishna Mani, Vignesh Kumar Balasubramanian and Swetha Kalaiselvan, Zifo RnD Solutions
Articulating ADaM Design Decisions: How to Communicate Your Analysis Dataset Design
Yugo Miki, FMD K&L Japan K.K.
Standardization of Statistical Documents Aiming for Automation of ADaM Specification Creation
Yumiko Asami, CSL Behring; Yasuyuki Okuda, Daiichi Sankyo; Masato Suzuki, MSD; and Azusa Tsukida, Sanofi
Looking Back: A Decade of ADaM Standards
Trevor Mankus, Pinnacle 21