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


  • Alberto  Grignolo, DIAFellow, PhD

    Alberto Grignolo, DIAFellow, PhD

    • Corporate VP PAREXEL Consulting
    • PAREXEL, United States

    Alberto Grignolo has 36+ years of experience as a regulatory and drug development professional including consulting for pharmaceutical and biotechnology companies. He is a driver of a successful worldwide consulting business and established PAREXEL’s Japan Consulting Services. He is an Executive Sponsor of drug development programs on behalf of clients and participates in PAREXEL’s Diversity and Inclusion initiatives and efforts for a High Performance Culture and excellent customer service.

  • Yoshiaki  Uyama, PhD

    Yoshiaki Uyama, PhD

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

    Yoshiaki Uyama is currently Office 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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