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San Diego Convention Center

Jun 15, 2014 8:30 AM - Jun 19, 2014 12:45 PM

111 W Harbor Drive, , San Diego, CA 92101 , USA

DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall

Session Chair(s)

Nobumasa  Nakashima

Nobumasa Nakashima

Professor, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Japan

Representatives from the Pharmaceuticals and Medical Devices Agency (PMDA) will explain its current services and the Japanese drug regulation, and answer your questions on PMDA’s future initiatives/challenges for faster review and better life cycle management of drugs.

Please come prepared with your questions for the PMDA Town Hall panel. You may submit questions and topics of interest in advance to annualmeetingprogram@diahome.org, and include “PMDA Town Hall” in the subject line.

Learning Objective : Discuss the current situation of PMDA and Japanese regulation; Communicate with PMDA senior officials on Japanese drug regulatory issues.

Speaker(s)

Tatsuya  Kondo, MD, PHD

Tatsuya Kondo, MD, PHD

President, SH Medical Excellence JAPAN, Japan

Future Plan of PMDA for the Next Five Years

Masaru  Hiraiwa

Masaru Hiraiwa

Director, Office of Planning and Coordination, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Introduction of the Third 5-Year Mid-Term Plan of PMDA

Tetsuo  Nagano, PHD

Tetsuo Nagano, PHD

Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

PMDA's Efforts in the Medical Area

Hiroshi  Yamamoto, MS

Hiroshi Yamamoto, MS

Chief Safety Officer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Safety Measures: The Risk Management Plan in Japan

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