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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

13th DIA Japan Annual Meeting 2016

[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

Rie Matsui, RPh

Senior Director, Regional Labeling Head for APAC, International Labeling

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

Impacts of the Amendment of Entry Procedures about Labeling in Japan: Global Labeling Management Point of View

Ryuhei Fujimoto, DVM, PhD

Astellas Pharma Inc., Japan

Director, CCDS & Labeling, Operating Platforms, Regulatory Affairs

Reiko  Sato, PhD

What is Expected to be Improved Japanese Package Insert under New Entry Procedures

Reiko Sato, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Deputy Director, Office of Safety II

Yoshihiro  Teshima, MS

Comparison of the Labels between the United States and Japan

Yoshihiro Teshima, MS

MSD K.K., Japan

Associate Director, Product Labeling & Registration, Japan Product Labeling

Toshinori  Higashi, PhD

Toshinori Higashi, PhD

KAKEN PHARMACEUTICAL CO.,LTD., Japan

Vice President, Regulatory Science

Junko  Sato, PhD

Junko Sato, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Associate Executive Director

Claudia  Hey, DrSc, PharmD

Claudia Hey, DrSc, PharmD

Merck Healthcare KGaA, Germany

Senior Director, Head Europe Global Regulatory & Scientific Policy

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