A comprehensive portal site for Medical Innovation Support Office (MEDISO).Medical Innovation Support Office

Osamu Tabuchi

JMDC Inc. Quality Assurance Office manager

I am a dedicated professional with extensive experience in safety management and post-marketing surveillance (PMS) in the pharmaceutical industry. After joining SANWA KAGAKU KENKYUSHO CO., LTD., I focused on risk management for diabetes medications and treatments for dialysis complications. My work included PMS literature development and cardiovascular event evaluations, contributing significantly to drug development.
At CureApp, Inc, a company specializing in software as medical devices, I served as the Safety Management Officer. I successfully established the safety management system and operational processes for Japan's first therapeutic app. My involvement in risk management for various therapeutic applications, including those for hypertension, allowed me to engage deeply with the core aspects of product development.
Currently, I am the Head of Quality Assurance at JMDC, Inc, where I oversee GxP compliance and reliability assurance. I am actively involved in building a new PMS framework that combines e-source data with additional collected data, as well as managing certification acquisition and maintenance.

Eiichi Yamaguchi

Eiichi Yamaguchi, Ph.D. President A1 Partners

Ph.D from Faculty of Pharmaceutical Sciences Kyushu University. Currently engaged in management and business development consulting for pharmaceutical companies, biotech ventures, and consulting firms. Over 20 years expertise of business development at Shionogi Co., Ltd., a major pharmaceutical company as well as bioventure companies. Senior Director, Business Development & Corporate Planning Dept., Shionogi. A lot of global business experience such as the first Managing Director, Shionogi Singapore, Vice President, Shionogi Qualicaps, Inc., North Carolina, and Shionogi New York. Board of Director & President & COO, a bioventure company. The first chairman, Japan Pharma Alliance Association. The Vice Chairman, Public Private Alliance Conference associated with Infectious diseases led by Dr. Shigeru Omi. Also engaged in Director, International Committee, JPMA. Last but not least, selected as Mentor for Blockbuster Tokyo 2021

Hiroyuki Kajiyama

Graduated from Kyoto University Faculty of Pharmaceutical Sciences. Worked at Tanabe Mitsubishi Pharma Corporation in pharmaceutical research and development, primarily handling clinical development tasks. Since 2016, employed at the Pharmaceuticals and Medical Devices Agency (PMDA), Review Management Department, as a Technical Expert in Regulatory Science Strategy Consultation. Engaged primarily in providing consultation services on pharmaceuticals, medical devices, regenerative medicine products, focusing on academia and venture companies.

Mirai Miyahara

President of i Access Consulting Inc.

Miyahara holds a Master's degree in Business Administration from the Graduate School of Economics at Tohoku University. She possesses 17 years of professional experience in Regulatory Affairs, QMS, business planning, and overseas marketing at a leading medical device company and Notified bodies in Japan. With a specific focus on multi-country regulatory compliance and extensive experience in overseas medical device markets, Miyahara has demonstrated proficiency in navigating the regulatory landscapes of diverse markets, including Japan, China, India, East Southern Asia, EU and the U.S. She has a proven track record of achieving success in supporting medical companies with regulatory compliance, facilitating international expansion, and establishing strategic partnerships with local entities. Miyahara is also an adviser for JETRO medical devices international expansion program.

Takayuki Hirose

Patent attorney, Hirose International Patent Firm

He graduated with a master’s degree from the Graduate School, University of Tokyo. Patent attorney. After working in the intellectual property department in a major company, he was involved in lawsuit-, adviser- and application-relating services at a lawyer's office, followed by establishing his own international patent attorney's office in 2017. He offers intellectual property strategies in cooperation with companies as an adviser for multiple companies, including the Japanese Organization for Medical Device Development, Inc., (JOMDD) and Shin Nippon Biomedical Laboratories, Ltd. Furthermore, he applies for patent rights and trademarks in a wide variety of areas. He is involved in intellectual property-related services that include medical devices and pharmaceutical products. When he applies for a patent in foreign countries, he offers application strategies by placing the most importance on client’s profit, for example, to give advice to receive a subsidy or to select a foreign agent at a reasonable price depending on the company’s size.