Overview
Online registration has been closed, but we still accept your registration at the venue. Time for registration is 9:30-10:00am on May 23.
Click here to view the program.
The BE study has been an important study in pharmaceutical development, and each region/country including Japan is considering and researching effectiveness of BE study methodologies. It should become even more important due to the recent generic drug promotion policy.
Under this situation, Japan DIA CMC Forum program committee designed a program focusing on the BE study for this year.
Each region/country has a different BE guideline. These guidelines were created based on BE and Quality control philosophy of each region/country. We consider it is crucial to understand these philosophy for the global pharmaceutical development in the future. In addition, new framework of BE study, such as Biowaiver and Biopharmaceutics Classification System (BCS), which are emerging in recent years, has been a focus of attention in Japan.
In this year’s CMC Forum, we will learn each region’s guideline philosophy, scientific approach (BCS, IVIVC) and regulatory approach for BE studies (Biowaiver, Bioequivalence of parenteral formulation).
We will also have a keynote lecture by Prof. Hiroyasu Ogata who is one of the leaders in the field of BE studies in Japan.
Program Committee
-
Fusashi Ishikawa, PhD, MSc Associate Biopharmaceutics Research Fellow, Formulation R&D Laboratories
Sumitomo Dainippon Pharma Co., Ltd., Japan -
Tadayoshi Fujisaki Associate Manager, New Drug Registration Group, CMC RA Dept., RA, Dev. & MA Div.
GlaxoSmithKline K.K., Japan -
Takeshi Hishikura Director, International Affairs
Japan Generic Medicines Association, Japan -
Yukio Hiyama, PhD Visiting Researcher
National Institute of Health Sciences, Japan -
Noriko Katori, PhD Division of Drugs
National Institute of Health Sciences, Japan -
Yoshihiro Matsuda, PhD Senior Scientist (for Quality), Pharmacist
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Satoshi Nagayama Principal Scientist
Pfizer Japan Inc., Japan -
Kazuhiro Okochi Associate Director, GMS Japan Quality Center
Takeda Pharmaceutical Company Limited, Japan -
Haruhiro Okuda, PhD Deputy Director General
National Institute of Health Sciences, Japan -
Rumiko Shimazawa, PhD Professor, School of Medicine
Tokai University School of Medicine, Japan -
Nobuyuki Suzuki, PhD Senior Director, Analytical and Quality Evaluation Research Laboratories
Daiichi Sankyo Co., Ltd., Japan
Have an account?