For over 15 years at the Ministry of Health, Labour and Welfare (MHLW), Hideyuki Kondo dealt with diverse regulations on drugs, medical devices, and regenerative medicine products. His work included GCP guidance, inspections, promoting clinical trials, pre-market review policies, and post-market safety measures. He also contributed to international collaboration at the European Medicines Agency on GCP topics.
In 20219, he joined Novartis Pharma K.K., leading project teams focused on drug and regenerative medicine development in Japan, including clinical trials. Currently, he heads the Regulatory Affairs Japan Immunology team, supporting drug development from a regulatory perspective. He also contributes to GCP topics as a member of the Japan Pharmaceutical Manufacturers Association.
He earned a Bachelor of Pharmaceutical Sciences from Kyoto University, an MBA in Health Sector Management from Duke University’s Fuqua School of Business, and a PhD in Biomedical Science from the Tokyo Women’s Medical University – Waseda University Joint Institution For Advanced Biomedical Sciences.
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