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#34: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development


  • Alberto  Grignolo, DIAFellow, PhD

    Alberto Grignolo, DIAFellow, PhD

    • Corporate Vice President
    • PAREXEL, United States

    Alberto Grignolo, Ph.D. is a Corporate Vice President at PAREXEL Consulting. A 25-year veteran of the firm, he recently established the firm’s Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He has been an active member of DIA since 1984, served on the DIA Board from 2000 until 2004, is the Editor of DIA Global Forum magazine, received DIA’s Global Inspire Award (Global Connector) in 2015 and was named a Fellow of DIA in 2017.

  • Yoshiaki  Uyama, PhD

    Yoshiaki Uyama, PhD

    • Director, Office of Medical Informatics and Epidemiology
    • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Yoshiaki Uyama is currently Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for pharmacoepidemiological safety assessment and regulatory science research relating to new drug review and safety measure. He was also a rapporteur of ICH E17 (MRCTs) expert working group.

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