Aiko Hosoi

Background

About Aiko Hosoi

I have Bachelor degree from Queens College of City University and Master of Science degree from Swedish Institute College of Health Science in New York. Since I moved back to Japan in 2013, I have accumulated about 8 years working experience in Regulatory, 4.5 years in Regulatory Affairs in IVD industry and 2.5 years in Regulatory Consulting at global CRO. Also, I have a total of 12 years working experience in both clinical Safety and post-marketed Safety. RA experience-Partial Change Application and Minor Change Notification submissions -PMDA consultations -Labeling update (Electronic Package Insert and IFU)-4 Kinds of business licenses update and maintenance|-CTN submission and maintenance -PMDA inquires and responses -Communications with PMDA, MHLW, Kanagawa Prefecture Health Agency, Medical Device Surveillance division in Toyo Metropolitan Institute of Public Health, and Kanto-Shinetsu Regional Bureau of Health and Welfare Safety Experience-Being in charge of GVP related operation as a Safety Manager -Case Processing and ICSR report submission to PMDA -SOP updates Inspection Experience: 2 GCP inspections 1 Sponsor Audit 1 Kanagawa Prefecture Audit in QMS and GVP for IVD Marketing Business License and Manufacturing License -1 PMDA document-based inspection for re-examination 1 TMG Audit in QMS and GVP for Highly Controlled Medical Device Business License for MAH (Program Medical Device)