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Japan Town Hall
Session Chair(s)
Daisuke Koga, MSc, RPh
Director, Office of International Strategy and Planning
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
This session will focus on the attractiveness of developing and obtaining marketing approval of pharmaceutical products in Japan from regulatory and industry perspectives, aiming to get rid of old-fashioned ideas and views about Japan.
Learning Objective : Discuss outdated misconceptions and “urban legends” about Japan when considering Research and Development (R&D) on new medicines in Japan; Examine the attractiveness of performing R&D in Japan, both from regulatory and industrial perspectives: attractive market, flexibility/predictability, designation for each product characters; Analyze the Roles and Prospects of the PMDA’s Overseas Offices.
Speaker(s)
Panelist
Sarah Rhee
Alexion Pharmaceuticals, Inc, United States
Vice President, Head of Global Regulatory Affairs
Panelist
Eri Sekine
CMIC Co., Ltd, Japan
Executive Vice President Data Business
Panelist
Shinichi Noda, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Division Director, Division of Planning and Management, Office of International