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Virtual

Jun 24, 2021 9:30 AM - Jun 24, 2021 12:30 PM

#041A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development

Instructors

Alberto  Grignolo, PhD

Alberto Grignolo, PhD

Editor-in-Chief, DIA Global Forum, DIA, United States

Alberto Grignolo, Ph.D. FDIA formerly served as Corporate Vice President, Corporate Strategy and Thought Leadership at Parexel, and established the Company's Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He is a champion of Diversity, Equity and Inclusion within and outside Parexel. Dr. Grignolo served as Chairman of the Regulatory Affairs Professional Society, and as President of FIDIA Pharmaceutical Corporation. He is a DIA Fellow, the Editor-in-Chief of DIA's digital magazine Global Forum, and served for two decades on the faculty of DIA's Regulatory Affairs: The IND, NDA, and Post-Marketing Training Course, which he taught in Japan, China, Korea, Europe, and the US.

Yoshiaki  Uyama, PhD, RPh

Yoshiaki Uyama, PhD, RPh

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science reserach 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 Group, ICH Pharmacoepidemiology Discussion Group. He is also served as a visiting proffesor in Chiba University and Nagoya University.

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