Tokyo, Japan

10th December 2019

Registration for this event has now closed.
Please contact the PHUSE Office for further information.

 

Theme:

REIWA: Real-world Evidence and Electronic Submission Inspired from PHUSE Working Groups Activities

 

Description:

Regulators, industries and academia have been very interested in how to use Real-world Data (RWD) in clinical development. Database research using RWD is also actively being considered in Japan. How we can better leverage existing RWD to improve the costs and efficiencies of research and development will be discussed.
Electronic data submission (eSubmission) in Japan will be mandatory from April 2020. We will invite panellists from experienced and non-experienced companies on eSubmission and conduct a round table discussion. Practical and operational challenges will be discussed for full implementation of eSubmission in 2020. The new era of Japan "REIWA" began on 1 May 2019. In the new era, we will revitalise PHUSE Working Groups activities in Japan to support industry transformation.

 

Location:

SAS Institute Japan,
6-10-1 Roppongi,
Roppongi Hills Mori Tower 11F,
Minato-ku, Tokyo, 106-6111, Japan.

 

Agenda:

Time

Presentation

Speaker

09.30–10.00 Registration
10.00–10.05 Welcome and Opening Remarks Takashi Kitahara,
Novartis
10.05–10.10 PHUSE Updates PHUSE Japan Management Secretariat*

 

Real-world Evidence Session

Moderated by:
Yosuke Nishida,
 Chugai Pharmaceutical

10.10–10.35

 

Real-world Data Processing with Open-source Tools and Standards

Masafumi Okada,

IQVIA

10.35–11.00 Handling Big Data Using SAS (HPDS2, HASH Object and FCMP) – Do Not Sort! Reduce Steps! Yutaka Morioka,

EPS Corporation
11.00–11.30 Coffee Break  
11.30–11.55 Data-driven Drug Development Using a Development-related Data Platform Including Real-world Data – Collaborate with Biostatisticians, Data Scientists and Data Managers with “Yaritainen” Passion!

Takamichi Baba,

Shionogi & Co.

 

11.55–12.20 Planning of Post-marketing Database Studies Using MID-NET Yosuke Fujii,
Pfizer
12.20–13.30

Lunch Break

12.35 - 13.00 Working Lunch:
SAS Viya & SAS Health Analytics Framework to Get Deeper Insights from RWD,
SAS Institute

13.30–14.10 PHUSE in Japan Yuki Ando,
PMDA
 

e-Data Submission Round Table Discussion

Moderated by:
Takashi Kitahara, Novartis

14.10–14.35

e-Data Submission Uncertainties from a Less-experienced Point of View

Takeyuki Shindo,
Meiji Seika Pharma

14.35–15.00

e-Data Submission Tips and Insights from More-experienced Point of View

Tomotaro Shiraishi,

A2 Healthcare Corporation

15.00–15.50 e-Data Submission Panel Discussion Panelists:
Takeyuki Shindo,
Meiji Seika Pharma
Takuma Oda,

Janssen Research & Development
Tomotaro Shiraishi,

A2 Healthcare Corporation
Koichi Yamaguchi,
Eli Lilly Japan
15.50–16.20 Coffee Break
16.20–17.50

PHUSE Japan Working Groups Discussions


Proposed Topics:
1. e-Data Submission
2. Real-world Evidence
3. Open-source Technologies
4. Topics from Attendees

Moderated by:

PHUSE Japan Management Secretariat*

(SDE participants will be asked to join one of the topics of interest, for group discussion).

17.50–17.55 Japan Working Groups Activities PHUSE Japan Management Secretariat*
17.55–18.00 Closing Remarks Yosuke Nishida,
Chugai Pharmaceutical
18.30–20.30 Networking Reception


Brochure:

Download the event brochure.

 

SDE Chairs:

Takashi Kitahara, Novartis

Yosuke Nishida, Chugai Pharmaceutical

If you have any questions, or require any information, please contact the SDE Chairs.

 

*PHUSE Japan Management Secretariat members:
Masashi Aonuma, EPS Corporation
Yukikazu Hayashi, A2 Healthcare Corporation
Takashi Kitahara, Novartis
Yuichi Nakajima, Novartis
Motohide Nishi, Medidata Solutions
Yosuke Nishida, Chugai Pharmaceutical
Yasunari Sadatsuki, CAC Croit Corporation
Ippei Akiya, Takumi Information Technology
Koichi Yamaguchi, Eli Lilly

 

Sponsors:

 

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