Back to Agenda
[V1-S5] Package Inserts after the Amendment of Entry Procedures in Japan: What Actually Changes from the Point of View of Patients and Global Stakeholders?
Session Chair(s)
Rie Matsui, RPH
Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan G.K., Japan
Japanese entry procedures for package inserts were recently modified, twenty years since the last amendments, and these alterations are certain to prompt a number of questions from authors, reviewers, and experts in Japan and other countries, and other stakeholders. The expected publication of Japanese package inserts in English also makes it mandatory to discuss and clarify the image of package inserts under these new procedures. This session will address questions such as: • Will new disparities occur between Japanese and global package inserts? • Are “prescription to special groups of patients” entry procedures consistent with global package inserts? Is it scientifically based? • Can the latest information on effectiveness be updated for international clinical trials in a timely manner? • Can the Japanese package insert be used as reference in the Asian region? Can problematic points be deleted for it to become reference? • Will important safety information necessary for the practice of health care professionals be properly described?
Speaker(s)
Ryuhei Fujimoto, DVM, PHD
Director, CCDS & Labeling, Operating Platforms, Regulatory Affairs, Astellas Pharma Inc., Japan
Impacts of the Amendment of Entry Procedures about Labeling in Japan: Global Labeling Management Point of View
Reiko Sato, PHD
Deputy Director, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
What is Expected to be Improved Japanese Package Insert under New Entry Procedures
Yoshihiro Teshima, MS
Associate Director, Product Labeling & Registration, Japan Product Labeling, MSD K.K., Japan
Comparison of the Labels between the United States and Japan
Toshinori Higashi, PHD
Vice President, Regulatory Science, KAKEN PHARMACEUTICAL CO.,LTD., Japan
Junko Sato, PHD
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Claudia Hey, DRSC, PHARMD
Senior Director, Head Europe Global Regulatory & Scientific Policy, Merck Healthcare KGaA, Germany
Have an account?