Division Director
Pharmaceuticals and Medical Devices Agency
Dr. Akihiro Ishiguro, PhD is a Division Director of the Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA). His professional experience includes new drug review and post marketing drug safety. He had the opportunity to join projects to develop regulatory guidelines in the area of Pharmacokinetics/Clinical Pharmacology including the MHLW guidelines (e.g., Drug Interaction, Population Pharmacokinetics) and the ICH guidelines (e.g., Qualification of Genomic Biomarkers, Genomic Sampling). Currently he is also working as a leader in an area of Pharmacokinetics in Offices of Drug review, PMDA; a leader of Omics working group, Projects Across Multi-Offices in PMDA; a regulatory chair of the ICH-M12 (Drug Interaction Studies) expert working group.
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Monday, April 25, 2022
8:00 AM – 1:30 PM ET
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