Andy has 25 years of pharmaceutical and CRO industry experience. He has supported a numbers of small biotech start-up companies to global pharmaceutical companies to make their regulatory strategy in Japan and facilitated PMDA consultation meetings. He and his team also prepare eCTD for Japanese NDA submission and follow-up regulatory communication. He graduated from University of Tokyo (majored in Applied Microbiology), and studies at Harvard Business School (PMD-63) . He used to work at OCED Biotechnology Unit to contribute to harmonization of government policy in biosafety. He is a member of DIA and Society for Regulatory Science of Medical Products (in Japan).

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH E15, E16 and E17 Expert Working Groups, and Pharmacoepidemiology Discussion Group. He is also served as a member of the DIA Council of Regulators and a board member of the international society for pharmacoepidemiology as well as a visiting professor in Chiba University (Graduate School of Medicine), Nagoya University (Graduate School of Medicine) and Nagoya City University (Graduate School of Pharmaceutical Science).