Program of events is subject to change.

Japan Interchange registrants will receive access to pre-recorded 2021 CDISC Europe Interchange presentations.

Session 1: Opening Plenary and Keynote Address

9:00 - 10:40
Akira Soma, Oracle, J3C Chair

9:00 - 9:30

Welcome Address & State of the CDISC Union

Dave Evans, CDISC President and CEO

9:30 - 10:10

COVID-19 Registry Japan(COVIREGI-JP)

Dr. Norio Ohmagari, Director, Disease Control and Prevention Center, National Center for Global Health and Medicine, Japan

大曲 貴夫

国立国際医療研究センター

国際感染症センター長

10:10 - 10:40

State of CDISC Standards

Bess LeRoy, CDISC Head of Standards Development

Break

10:40 - 11:10

Session 2: CDISC Updates

11:10 - 12:40
Dr. Takuhiro Yamaguchi, Tohoku University Hospital, J3C

11:10 - 11:40

CDISC 360 Update

Peter Van Reusel, CDISC Chief Standards Officer

11:40 - 12:10

CDISC Library Update

Anthony Chow, CDISC Director of Data Science

12:10 - 12:40

CRF Library

Alana St. Clair, CDISC Project Manager

Lunch

12:40 - 13:40

Session 3

13:40 - 15:50
Dr. Shiro Hinotsu, Sapporo University Hospital, J3C

13:40 - 14:20

PMDA Update

Dr. Yuki Ando and Daisuke Iwata, PMDA

14:20 - 14:50

Enhancement of the Role of Clinical Programming in the Age of CDISC

Yasutaka Moriguchi and Natsumi Kawase, GlaxoSmithKline K.K.

14:50 - 15:20

Simplifying the Integration Riddle

Arvind Sri Krishna Mani, Zifo RnD Solutions

15:20 - 15:50

Submitting Data with Japanese Characters to PMDA: The UTF-8 and Other Encodings Discussion

Dr. Jozef Aerts, XML4Pharma

Break

15:50 - 16:20

Session 4

16:20 - 17:30
Dr. Yuki Ando, PMDA

16:20 - 16:50

The Age Old Problem: A Discussion of Age Derivation and Imputation Techniques

Will Greenway and Joel Clarke, Quanticate International Ltd.

16:50 - 17:30

EMA Presentation

Dr. Frank Pétavy, Head of Methodology, European Medicines Agency

Session 5

9:00 - 10:30
Dr. Toshiki Saito, Nagoya Medical Center, J3C

9:00 - 9:30

FDA CDER Presentation

Helena Sviglin, FDA CDER

9:30 - 10:00

FDA CBER Presentation

10:00 - 10:30

Q&A Session

Break

10:30 - 11:00

Session 6

11:00 - 12:30
Dr. Hideto Yokoi, Kagawa University Hospital, J3C

11:00 - 11:30

Utilizing CDISC SEND Data to Generate Historical Control Incidence from a Large Database of Toxicology Studies

William Houser, Bristol Myers Squibb / BioCelerate

11:30 - 12:00

Create the Define.XML v2.1 with Python

Hengwei Liu, Daiichi Sankyo, Inc.

12:00 - 12:30

NMPA Submissions

Yiyuan Ma, Sanofi

Lunch

12:30 - 13:30

Session 7

13:30 - 15:00
Hideaki Kosaka, CAC Croit Corporation, J3C

13:30 - 14:00

Use Cases Report on Integrated Analysis and Legacy Data Conversion

Miu Susuki, JCROA

14:00 - 14:30

Challenges in Submitting CDISC Datasets to Multiple Regulatory Agencies: Toward a New Stage of Standards

Hiroshi Haneji, Sanofi, JPMA

14:30 - 15:00

Gap Analysis of CDISC Standards Implementation in Academia and CDISC-Annotated CRF Repository in Japan (AMED project)

Dr. Toshiki I. Saito, NHO Nagoya Medical Center

Break

15:00 - 15:30

Session 8: Closing Plenary

15:30 - 16:55
Hidemi Hasegawa, Boehringer Ingelheim, J3C

15:30 - 16:00

CDISC Presentation

John Owen, CDISC Head of Business Development

16:00 - 16:45

CDISC Q&A

Peter Van Reusel, CDISC Chief Standards Officer

16:45 - 16:55

Closing Remarks

Akira Soma, Oracle, J3C Chair