Associate Senior Scientist for Clinical Pharmacology and Pharmacokinetics
Pharmaceuticals and Medical Devices Agency (PMDA)
Shinichi Kijima is Associate Senior Scientist for Clinical Pharmacology and Pharmacokinetics in PMDA, Japan. After graduating from Meiji Pharmaceutical University, since 2009, he has over 10 years’ experience reviewing the pharmacokinetics, clinical pharmacology and pharmacometrics of new drugs. From 2016 to 2017, he worked as ORISE Fellow for Division of Pharmacometrics, OCP/OTS/CDER/U.S.FDA. In PMDA, he is lead pharmacometrician of Modeling and Simulation team. He contributed to development of Japanese pharmacometrics related guideline including PBPK guideline, Exposure-Response guideline and Population approach guideline published by the Ministry of Health, Labour and Welfare (MHLW), Japan. He was the leader on developing of the Japanese PBPK guideline in PMDA. He serves as MHLW/PMDA’s Topic Leader on the ICH E11A (Pediatric Extrapolation) Expert Working Group.
Saturday, May 31, 2025
8:30 AM - 3:00 PM East Coast USA Time