November, 2012

Conference Invitation
Using observational data for safety, effectiveness and value of pharmaceuticals
EFPIA Japan (Chairman: Philippe Fauchet）is delighted to organise the scientific conference on
the topic above and to extend its invitation.
One of the missions of EFPIA Japan is to share its experience and that of its member companies
with all stakeholders, in this case, in the field of observational studies and patient outcomes. In
Japan, there is also a growing interest for an appropriate infrastructure and data access tomeasure the outcomes of therapies beyond efficacy and safety, to include economic evaluationand patients’ quality of life. This conference will showcase experiences in Europe and the USA andhow they relate to the situation and challenges in Japan. We hope that, by looking at this topic fromvarious angles, EFPIA can contribute to the improvement of the healthcare environment in Japan.
Our keynote speaker will be Nancy A. Dreyer, MPH, PhD, who brings to Japan her experience inpharmacoepidemiology and, specifically, will share examples of observational and outcomesstudies、 Dr. Dreyer is Chief of Scientific Affairs at Quintiles Outcome and a director of theInternational Society for Pharmacoepidemiology (ISPE). She sits on the steering committee ofprojects in the Innovative Medicines Initiative (IMI), a joint programme of the EU commission andEFPIA and is also one of the senior editors of a handbook “Registries for Evaluating Patient
Outcomes: A User’s Guide”, prepared for the US government Agency for Healthcare Research andQuality (AHRQ).
Dr. Kiyoshi Kubota, University of Tokyo, will comment on Japan’s Standardized Structured Medical
record information eXchange (SS-MIX) and future studies on Risk Management Programmes,
while Dr. Mie Ikeda, PMDA, will report on the utilisation of electronic medical records for the safety
evaluation of pharmaceutical products in relation to a project currently steered by the PMDA.
We look forward to your participation in this conference.
European Federation of Pharmaceutical Industries and Associations (EFPIA)
Chairman Philippe Fauchet‐ Programme details ‐Tuesday December 4, 2012 from 14:00～17:00 (Doors open at 13:30)
Shin Marunouchi Building, Conference Center 9F(Address) 1-5-1 Marunouchi, Chiyoda-Ku, Tokyo (see directions enclosed)(Phone) 03-3217-7511【Speakers】 Dr Nancy A Dreyer (Chief of Scientific Affairs, Senior Vice President,Quintiles Outcome）
Dr Mie Ikeda (Director Office of Safety 1, Pharmaceutical and Medicines
Devices Agency)【Co-chairs】 Dr. Kiyoshi Kubota (Professor of Pharmacoepidemiology, Faculty ofMedicine, University of Tokyo)
Mr. Masuhiro Kato (Senior Advisor to EFPIA, Chairman, Astra Zeneca)【Date】【Location】【Simultaneous translation will be available】
Please confirm your attendance by fax or e-mail to the conference secretariat
with your name, organisation and contact details
before Friday November 30, 2012
【Admission】 freeFor further information, please contact the conference secretariat
J. Public Relations, Inc.: Endo, Yamamoto, Yamada,
Tel: 03-4531-1745 e-mail / efpia-meec@k-jpr.com
EFPIA Japan: Ryo Iwata (Bayer Yakuhin, Ltd.)
Tel: 03-6266-7116

The conference secretariat（JPR）

FAX：03-3265-5267
Conference Invitation
Using observational data for safety,effectiveness and value of pharmaceuticals
Tuesday December 4, 2012 from 14:00～17:00 (Doors open at 13:30)
Shin Marunouchi Building, Conference Center 9F
Address: 1-5-1 Marunouchi, Chiyoda-Ku, Tokyo (see directions enclosed)
Phone： 03-3217-7511□I will attend□I will not attend＜Shin-Marunouchi Building
Conference Square＞

Imperial Palace

The conference square is on the 9th floor. Please
use the elevator located near the front desk of thebuilding's office entrance.

Marunouchi
Building

Shin -Marunouchi
Building

Marunouchi Line Tokyo Sta.

Marunouchi
OAZO＜access by rail&subway＞
Tokyo Sta.(JR):Marunouchi North Gate:approx. 1-minute walk /Direct connection from Marunouchi Central Gate(basement level)via the sheltered undergroundpedestrian network.
Tokyo Sta. (Marunouchi Line):
Direct connection via Concourse

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