Thank you for attending the 2019 Japan Interchange. You will find presentations from the Main Conference below.
Session 1: Opening Plenary & Keynote Address
Welcome Address & State of the CDISC Union
David R. Bobbitt, CDISC President and CEO
Keynote Presentation: Use of Clinical Information - A New Age
Dr. Mihoko Okada, President, Institute of Health Data Infrastructure for All
Second Plenary: Evolution of the CDISC Standards
CDISC 360 Introduction
Peter Van Reusel, CDISC
CDISC Library Update
Mike Hamidi, CDISC
Session 3: Academia & Real World Data
PMDA Update: Experiences and Current Status
Kumiko Takeuchi, PMDA
PMDA Update: Technical Update and Points to be Considered
Dr. Yuki Ando, PMDA
Briefing of "Workshop for Promoted Use of CDISC at Academia in Japan"
Dr. Shiro Hinotsu, Sapporo Medical University
CDISC standards for Real World Data initiatives in the SCRUM-Japan Registry
Yasutoshi Sakamoto, National Cancer Center Hospital East; and Kaname Shiratake, EPS Corporation
CDISC and Real-World Studies
Abhishek Banerjee, Tata Consultancy Services
Session 4: Machine Learning & Automation
Proof of concept of utilizing NLP and machine learning models for mapping raw data to SDTM
Sam Tomioka, Sunovion Pharmaceuticals
Creation of Regulatory Submission Data Using Machine Learning
Giri Balasubramanian, PRA Health Sciences
Raising the bar for data standardization: How to ensure your submission data supports automated review process at FDA and PMDA?
Chikaaki Nakao, Pinnacle 21
Machine Learning Approach to Identify Source and Target Variables from Historical SDTM SAS Programs to Build Mapping Library
Venkatesh Yanamadala, PRA Health Sciences
Session 5: Presentations by EMA
Big Data – Challenges and Opportunities: Moving forward with recommendations from the HMA-EMA Joint Big Data taskforce
Dr. Alison Cave, Pharmacovigilance and Epidemiology Department; and Dr. Frank Petavy, Research & Development Support Division, European Medicines Agency
Session 6: Third Plenary – Regulatory Presentations
The Impact of SEND on FDA Review of Nonclinical Study Data
Dr. Matthew Whittaker, Office of New Drugs, Center for Drug Evaluation and Research, FDA
Safety Review: Approach & Tools
Dr. Alan Shapiro, Office of Computational Sciences, Center for Drug Evaluation and Research, FDA
Session 7A: SEND
Status of SEND efforts of the SEND development team and the CJUG SEND team
Terukazu Kitahara, CJUG-SEND
De-identification and Sharing of Nonclinical CDISC SEND Datasets: Experience and Plans from BioCelerate and JPMA
William Houser, Biocelerate; and Gen Sato, JPMA
CDISC Standards for Animal Rule Studies
Jon Neville, CDISC
Session 7B: eSubmissions
Legacy data conversion and Linking to External Dictionaries
Masataka Higashijima, Eli Lilly Japan
A New Way to Generate Analysis Result Metadata for Define-XML from Enterprise Pinnacle 21
Rong Zhang, Pfizer China
Moving to Define XML v2.1
Chao Wang, FMD K&L
Session 8A: ODM & Observational Data
FHIR to EDC via ODM
Arvind Sri Krishna Mani, Zifo RnD Solutions
A Joint Venture: DRG-XML & ODM4Submission
Mike Hamidi, CDISC
Use of CDISC Standardized Observational Data to Support Regulatory Decisions
Bess LeRoy, CDISC
Session 8B: MDR
MDR Requirements for Study Build and Implications for the CDISC Library
Philippe Verplancke, XClinical GmbH
How to Complete MDR? A SAS Programming Approach for Auto-SDTM aCRF
Kyle Chang, PAREXEL International
Challenges of CDISC Metadata Repository Implementation
Miho Hashio, GlaxoSmithKline
Session 9: CDISC Use Cases
Data Anonymization Using SDTM Standards
Arvind Sri Krishna Mani, Zifo RnD Solutions
Quality management for statistical analysis of post marketing surveillance based on CDISC standards and risk-based approach
Yumiko Asami, Daiichi Sankyo
CJUG Update
Yoshiteru Chiba, CJUG, J3C
JPMA Update
Sho Hibino, JPMA
JCROA Update
Nao Makino, JCROA