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DIAmond Session: Patient-Engaged Drug Development in Japan, US, and Europe
Session Chair(s)
Yoshinobu Hirayama, PhD
Professor, College of Pharmaceutical Sciences
Ritsumeikan University, Japan
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)
Informing Benefit-Risk Assessment With Patients’ Perspectives: FDA Patient-Focused Drug Development
Theresa Mullin, PhD
FDA, United States
Associate Center Director - CDER
Patient-Engaged Drug Development - EMA
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
Patient-Engaged Drug Development in Japan
Kazuhiko Mori, PhD, MSc
Japan Pharmaceutical Manufacturers Association (JPMA), Japan
Former Executive Director