Program of events is subject to change.

10 Jul 2019

Use of CDISC Standards in Academia Workshop

Ito Hall, B2F
13:30 - 17:30

Opening Remarks

Dr. Takahiro Kiuchi, UMIN Center, the University of Tokyo Hospital

 

 

Introductory Remarks: Challenges and Opportunities for Standardizing Academic Research

David R. Bobbitt, CDISC President and CEO

TA Development Update

Bess LeRoy, CDISC

CDISC Library Update

Mike Hamidi, CDISC

CDISC Education in Academia - Vision and Challenges

Dr. Takahiro Kiuchi, UMIN Center, the University of Tokyo Hospital

Use cases in drug trials and standardization of CDISC implementation in hemato-oncology

Mr. Matsuo Yamamoto, NHO Nagoya Medical Center, Clinical Research Center

Experience of Data Convert into CDISC Format from Meta-analysis Dataset

Dr. Shiro Hinotsu, Sapporo Medical University

Report of AMED-sponsored Project "Research for Conversion of Medical Information Standardized with SS-MIX Format into CDISC"

Mr. Yoshiteru Chiba, UMIN Center, the University of Tokyo Hospital

Standardization of Output Environment for Clinical Trial Data from Hospital Information System

Yoshihiro Aoyagi, National Cancer Center Hospital East

Overview of ICH-E8(R1) - General Considerations for Clinical Studies

Dr. Mutsuhiro Ikuma, PMDA

The possibilities and issues of Medical AI

Dr. Nobuyuki Ota, Preferred Medicine, Inc.

Closing Remarks

Peter Van Reusel, CDISC
11 Jul 2019

Registration

Ito Hall Foyer
08:30 - 17:00

Exhibition Open

Ito Hall Event Space, B2F
10:00 - 20:00

Poster Session

Ito Hall Foyer, B2F
10:00 - 20:00

Opening Plenary

Dr. Shiro Hinotsu, J3C
Ito Hall, B2F
09:00 – 10:15

Welcome Address & State of the CDISC Union

David R. Bobbitt, CDISC President and CEO

Keynote Presentation

Dr. Mihoko Okada, President, Institute of Health Data Infrastructure for All

Break

Ito Hall Event Space, B2F
10:15 - 10:45

Second Plenary: Evolution of the CDISC Standards

David R. Bobbitt, CDISC President and CEO
Ito Hall, B2F
10:45 – 12:15

CDISC 360 Introduction

Peter Van Reusel, CDISC

CDISC Library Update

Mike Hamidi, CDISC

Lunch

12:15 – 13:30

Session 3: Academia & Real World Data

Dr. Hideto Yokoi, J3C
Ito Hall, B2F
13:30 – 15:15

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

Break

Ito Hall Event Space, B2F
15:15 – 15:45

Session 4: Machine Learning & Automation

Dr. Toshiki Saito, J3C
Ito Hall, B2F
15:45 – 17:05

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

Short Break

Ito Hall Event Space, B2F
17:05 - 17:15

Session 5: Presentations by EMA

Dr. Yuki Ando, PMDA, J3C
Ito Hall, B2F
17:15 – 18:15

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

Evening Networking Event

Ito Hall Event Space, B2F
18:15 – 20:00
12 Jul 2019

Registration

Ito Hall Foyer, B2F
08:30 - 12:00

Exhibition Open

Ito Hall Event Space, B2F
10:00 - 16:30

Poster Session

Ito Hall Foyer, B2F
10:00 - 16:30

Session 6: Third Plenary – Regulatory Presentations

Satoru Tsuchiya, J3C
Ito Hall, B2F
09:00 – 10:30

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

FDA-CDER Presentation

Dr. Alan Shapiro, Office of Computational Sciences, Center for Drug Evaluation and Research, FDA

Roundtable Discussion with FDA, PMDA & CDISC

Break

Ito Hall Event Space, B2F
10:30 – 11:00

Session 7A: SEND

Yoshinori Fujimura, J3C
Ito Hall, B2F
11:00 – 12:30

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

Satoko Tamamura, J3C
Gallery 1, B1F
11:00 – 12:30

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

Lunch

12:30 – 14:00

Session 8A: ODM & Observational Data

Yoshiteru Chiba, J3C
Ito Hall, B2F
14:00 – 15:30

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

Akira Soma, J3C
Gallery 1, B1F
14:00 – 15:30

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

Break

Ito Hall Event Space, B2F
15:30 – 16:00

Session 9: CDISC Use Cases

Dr. Takuhiro Yamaguchi, J3C
Ito Hall, B2F
16:00 – 17:30

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, JPMA, JCROA Updates

Closing Remarks

Hidetoshi Misawa, Pfizer, J3C Chair