Akihiro Ishiguro

Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management, and regulatory science research promotion. He had the opportunity to join projects to develop regulatory guidelines in the field of Clinical Pharmacology such as the MHLW guidelines (e.g., Drug Interaction, Population Pharmacokinetics, Exposure Response Analysis) and the ICH guidelines (e.g., Qualification of Genomic Biomarkers, Genomic Sampling). He had also worked as a leader in the field of Pharmacokinetics in Offices of Drug Review, PMDA; a leader of Omics working group, Project across multi-offices in PMDA; a regulatory chair of the ICH M12 (Drug Interaction Studies) expert working group. He received his PhD degree in Pharmaceutical Sciences from the Chiba University, Japan in 2009.