Dr. Hiroko Shibata is a Section Chief at the National Institute of Health Sciences, Japan. (NIHS). After receiving her Ph.D. in Pharmaceutical Science in 2007 from Osaka University, she joined the Division of Drugs of the NIHS in April 2007. She was responsible for pharmaceutical evaluation of drug products and investigating evaluation methods for complex generic drugs. Since October 2016, she has been a Section Chief of Division of Biological Chemistry and Biologicals. She is a member of the Japanese Pharmacopoeia Expert Committees for drug formulation and biologicals, and also an advisor of the review of new biopharmaceutical drugs submitted for registration. She also joins the Expert Working Group of ICH Q2(R2)/Q14 as a Topic Leader.