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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

13th DIA Japan Annual Meeting 2016

DIAmond Session: Patient-Engaged Drug Development in Japan, US, and Europe

Session Chair(s)

Yoshinobu  Hirayama, PhD

Yoshinobu Hirayama, PhD

Professor, College of Pharmaceutical Sciences

Ritsumeikan University, Japan

Kihito  Takahashi

Kihito Takahashi

Head of R&D/Medical Affairs Hub Japan

Swedish Orphan Biovitrium (SOBI) Japan, Japan

In recent years, there have been active discussions to bring patient perspectives into drug development, evaluation, and so on. The US and Europe have already implemented initiatives for patient engagement and some outcomes are available. It is expected that patient engagement initiatives will be promoted in Japan as well. This session will share the backgrounds, goals, achievements, and challenges of these initiatives in the US and Europe, followed by discussion among experts from Japan, US, and Europe about the aims for patient-engaged drug development in Japan.

Speaker(s)

Theresa  Mullin, PhD

Informing Benefit-Risk Assessment With Patients’ Perspectives: FDA Patient-Focused Drug Development

Theresa Mullin, PhD

FDA, United States

Associate Center Director - Strategic Initiatives, CDER

Agnès  Saint-Raymond, DrMed

Patient-Engaged Drug Development - EMA

Agnès Saint-Raymond, DrMed

European Medicines Agency, Netherlands

Head of Division International Affairs

Kazuhiko  Mori, PhD, MSc

Patient-Engaged Drug Development in Japan

Kazuhiko Mori, PhD, MSc

Japan Pharmaceutical Manufacturers Association (JPMA), Japan

Senior Managing Director

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