Back to Agenda
Session 6 / Venue 3: How to keep a Good Drug with Positive B/R Balance for a Long Period after Approval
Session Chair(s)
Yoshiaki Uyama, PhD, RPh
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
While post-marketing drug safety evaluation has been strengthened, there is growing concern that the process focuses more on risk of the product than the benefit. The imbalanced evaluation overestimates the negative aspect, which may result in withdrawn from the market unreasonably. It is critical to evaluate the benefit and the risk equally to maintain a supply of necessary drug to the patients, but the process of benefit evaluation still remain unargued. This session will deliver speeches about how to garner evidence of benefit for appropriate post-marketing benefit/risk evaluation. The speakers will discuss future evaluation model at panel discussion.
Speaker(s)
What is the right benefit/risk assessment?
Kazuhiko Mori, PhD, MSc
Japan Pharmaceutical Manufacturers Association (JPMA), Japan
Senior Managing Director
New paradigm on benefit/risk evaluation
Masahiro Takeuchi, DrSc, MPH
Kitasato University School of Medicine, Japan
Professor,Dept. of Clinical Medicine (Biostatistics & Pharmaceutical Medicine)
A way to conduct the appropriate benefit/risk evaluation: Industry’s perspective
Hironobu Saito, PhD
Tottori University, Chromosome Egineering Research Center, Japan
Specially Appointed Professor
Have an account?