| Noriaki Nagao has an expertise of Monitoring and Quality Control. He joined Japan Tobacco INC. Pharmaceutical Division, Clinical Development Department in 2004, and has over 11 years of experience in Clinical Development. He was responsible for providing monitoring activities from site selection to site closeout, ensuring GCP compliance, identifying and finding resolution to monitoring issues, training CRA/Investigators/other site personnel as Clinical research Associate (CRA) in the areas of lipid metabolism, diabetes, and cardiovascular for 7 years. Now he is responsible for educating in-house CRAs and CRAs in other companies as a GCP specialist in Quality Control group from 2011. The topics of the training include GCP, internal SOPs, notifications from regulatory authority, and overall practices for monitoring activities. Additionally, he works in some drug industry organizations that consist of clinical study specialists from many pharmaceutical companies, CROs and medical personnel, and provides practical deliverables to contribute for high GCP compliance and quality of clinical trials in Japan. |