Dr. Kentaro Hara has 16 years of experience in PMDA Japan, including 3 years as a CMC reviewer and 13 years as a GMP inspector.  He conducted many on-site GMP inspections in India, China and other countries.  He was a member of ICH Q7 IWG and ICH Q12 EWG.  

Currently, he manages GMP Inspection Division of PMDA and is also a member of the PIC/S Executive Bureau (2022-2025).  He aims to expand information sharing network with PIC/S participant authorities and ensure effective GMP regulations into the PIC/S.

Throughout the past ten years, he has learned a lot from GMP authorities of other countries by participating in the collaborative activities and has brought the quality of PMDA's GMP inspection to the global level.

Next ten years, he will work to further strengthen cooperation within GMP authorities in the Asia Pacific region.

Technical Background: Doctor’s degree in Biosciences from the University of Tokyo

PMDA: Pharmaceuticals and Medical Devices Agency

PIC/S: Pharmaceutical Inspection Co-operation Scheme