Back to Agenda
Session 4 / Venue 3: Past, current and future of Benefit Risk Balance assessment-Where we are and where we will be
Session Chair(s)
Osamu Komiyama
Senior Manager, Statistical Research & Data Science
Pfizer R&D Japan G.K., Japan
In EU/US, industries and governments have worked on the establishment of the methodology on benefit-risk balance assessment since around 2006. The part of benefit was created in Module V Risk management plan, which is new GVP regulation in July 2012 in EU. It was changed from traditional vision focusing mainly on safety to concept of benefit including the patient’s viewpoint systematically. In DSUR, the similar consideration is employed. Furthermore, in PDUFA V, which was started from last October in US, it was stated that the methodology of them will be established within five years. Meanwhile, in Japan, the discussion of them was just started under the leadership of the industries in 2012, and it was argued about the necessity for cooperation activity between industries and governments in the DIA last year. In this session, speakers from EU/US and Japan will introduce trials and experiences from past to present and will share an idea regarding future plans and direction.
Speaker(s)
Overview for Benefit-Risk Assessment for Medications
Tomomi Kimura, MD, PhD
Janssen Pharmaceutical K.K., Japan
TF Lead, TF1, JPMA Data Science Subcommittee
Expectation for PBRER and its foresight – Insights from current situation both in EU and in Japan
Junko Sato, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
IMI-PROTECT Work Package 5 - Concept, results and the future of benefit-risk integration and representation in medicine
Deborah Ashby, PhD, MSc
Imperial College London, United Kingdom
Professor of Medical Statistics and Clinical Trials
BR balance assessment during life cycle of medicinal products (TBC)
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Have an account?