Program of events is subject to change.

20 May 2020

CDISC Standards in Academia Workshop

Opening Remarks

Peter Van Reusel, CDISC Chief Standards Officer

CDISC Strategy to Support Academic Research

Peter Van Reusel, CDISC Chief Standards Officer

AMED Project - Research on inter-institutional Collaboration for Promoting Use of CDISC Standards in Academia

Dr. Toshiki Saito, Director, Department of Regenerative Medicine, Clinical Research Center, National Hospital Organization Nagoya Medical Center

Challenge to Promote the Use of CDISC Standards in Academia Organizations - Case of Clinical Research Data Center at Tohoku University Hospital

Dr. Takuhiro Yamaguchi, Professor at Division of Biostatistics, Tohoku University Graduate School of Medicine and Director of Clinical Research Data Center, Tohoku University Hospital

A Case of Data Management in Conformity with CDISC/SDTM in Academia - Kanazawa University –

Dr. Shizuko Takahara, Assistant Professor, Innovative Clinical Research Center, Kanazawa University

Some TIPS for collaboration with Academia based on an experience of assessing convertibility of ISS study data to CDISC compliant data format

Yumiko Kawabata, Biostatistics Group, Biostatistics & Programming, Clinical Science and Operation, R&D, Sanofi KK

CRO Support for Investigator-Initiated Clinical Trials

Issaku Tabata, Japan CRO Association

CDISC Education in Japan

Yoshiteru Chiba, University Hospital Medical Information Network

Tips to Obtain Useful Information to Implement CDISC Standards

Hidemi Hasegawa, Data Science Expert Committee, Japan Pharmaceutical Manufacturers Association

Use of CDISC Standardized Observational Data to Support Regulatory Decisions

Bess Leroy, Head of Standards Development, CDISC

Challenge to Apply CDISC Standards to Observational Study Data Obtaied from Recept Data (JMDC)

Dr. Shiro Hinotsu, Professor, Department of Biostatistics, Sapporo Medical University

Closing Remarks

Dr. Takahiro Kiuchi, Director, UMIN Center, the University of Tokyo Hospital Professor, Department of Health Communication
21 May 2020

Session 1: Opening Plenary & Keynote Address

9:00 - 10:10

Welcome Address & State of the CDISC Union

David R. Bobbitt, CDISC President and CEO

Keynote Address

Dr. Yasuhiro Fujiwara, Chief Executive, PMDA

Second Plenary: Evolution of the CDISC Standards

10:40 - 12:20

CDISC 360: The Journey So Far and the Road Ahead

Peter Van Reusel, CDISC

State of the CDISC Standards

Bess LeRoy, CDISC

CDISC Library Update

Mike Hamidi, CDISC

CDISC RWD Connect

Rhonda Facile, CDISC

Lunch Break

12:20 - 13:40

Session 3: Regulatory & Academia

13:40 - 14:55

PMDA Update: Experiences and Current Status

TBD, PMDA

PMDA Update: Technical Update and Points to be Considered

Dr. Yuki Ando, PMDA

Briefing from "Workshop for Promoted Use of CDISC at Academia in Japan"

Dr. Shiro Hinotsu, Sapporo Medical University

CDISC Strategy to Support Academic Research

Peter Van Reusel, CDISC

Session 4: Master Track

15:25 - 16:55

Cross-Research Meta-Analysis using CDISC Standards

Mike Hamidi, CDISC

SDTM Implementation Deep Dive

Bess LeRoy, CDISC

Upcoming CDISC Website Content (Knowledge Base, Examples Collection, CRF Library)

Mike Hamidi, CDISC

Session 5: Presentation by EMA

EMA Presentation

TBD

Evening Networking Event

18:05 - 19:50
22 May 2020

Session 6: Third Plenary - Regulatory Presentations

9:00 - 10:30

FDA Presentation

Dr. Matilde Kam, FDA-CDER

FDA Presentation

Helena Sviglin, FDA-CDER

FDA Presentation

Dr. Alan Shapiro, FDA-CDER

Roundtable Discussion with PMDA, FDA and CDISC

Session 7: eSubmission

11:00 - 12:00

Standardization and continuous improvement of eData submission process

Nao Makino, EPS Corporation, JCROA

CDISC Implementation in JPMA companies: behind the scenes

Naoto Awaji, Chugai

Lunch Break

12:00 - 13:30

Session 8A: SDTM

13:30 - 14:45

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

Session 8B: CDISC Use Cases

13;30 - 14:45

Simplifying the Integration Riddle

Arvind Sri Krishna Mani, Divya P and Amara Bharathy, Zifo RnD Solutions

CDISC standards with Python and data pipelines

Denislav Ganchev, Biodome Clinical Ltd.

Introduction of A New Concept: Analysis Results Data Model (ARDM)

Stanley Wei, Novartis

Session 9A: ADaM

15:15 - 16:30

Looking Back: A Decade of ADaM Standards

Trevor Mankus, Pinnacle 21

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

Session 9B: SDTM/SEND

15:15 - 16:30

Development of a SEND data model and accompanying QC checks

Gitte Frausing, Data Standards Decisions Aps

Using SEND Data Sets to Enable Large-Scale Data Analytic Approaches for Preclinical Toxicology Data

William Houser, Bristol Myers Squibb / BioCelerate

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

Closing Plenary: Evolution of the CDISC Standards

16:45 - 17:45

AI and Machine Learning for Processing CDISC Documents like RWD Survey Data

Dr. Wenjun Bao, CDISC Board of Directors, JMP Life Sciences

Use of CDISC Standardized Observational Data to Support Regulatory Decisions

Bess LeRoy, CDISC

Closing Remarks

Hidetoshi Misawa, J3C Chair, Pfizer