This research was carried out to review the current state of thinga involving trainees (students and business workers) accepted by Anjo-Kosei Hospital and to clarify the role the Education Center in our hospital is expected to play in supporting trainees. The subjects were medical and non-medical students and business workers who signedup for our internship program and junior and senior high school students who paticipated in the hands-on training program at Anjo-Kosei Hospital between April 2006 and March 2009. A total of about 1,300 students and business workers had experienced the actual hands-on work each year. The number of medical students accepted was 289, 289, and 339 in 2006, 2007, and 2008, respectively. Besides, the number of non-medical students also increased from 847 to 1,045 in the period of three years. The business workers accepted came from 15 different types of occupation. It was found that junior and senior high school students were interested in the nursing-care field and this seemed to help them consider seriously their life as students and members of society, leading to the increased number of students who joined our program. In addition, unfortunately, two-fifths of the program were unfavorable for trainees because of poor management. The present research suggested that the Education Center take on a signification role in managing the internship and the hands-on training programs to accelerate the potential of students and business workers.

In Japan, a re-examination system was introduced in the 1970s, and Post-marketing surveillance (PMS) has been conducted in many cases after the launch of new drugs or the approval of new indications for existing drugs. The revised Good Post-marketing Study Practice (r-GPSP) was enacted in 1 April 2018, and more scientific approach has been required for PMS. The survey aims to identify what kinds of change occurred in the PMS planned after r-GPSP enacted. As for the study method, after confirming the review report of each product, Risk Management Plan (RMP), and the package insert, and extracting necessary items, tabulation and analysis were performed. As a result of analysis, Drug Use Investigations (DUI) still accounted for more than 60％ of the total in PMS. Regarding the target number of DUI, Fifty-eight out of 90 had a sample size of 500 or fewer, only 3 studies exceeded 3,000. Regarding the newly introduced Post-marketing database surveillance (DB study) after r-GPSP enacted, 13 products and 18 surveillances were confirmed, although the number was not as large as the number of DUI. The most used database was Medical Data Vision Co., Ltd. (MDV), which were used in twelve DB studies, and cardiovascular disease and interstitial pneumonia were set as survey targets for safety considerations in multiple studies. There was no Drug Use Comparative Investigation. Furthermore, there were two products which were approved on the condition with re-examination period but did not required additional Pharmacovigilance activities. In terms of sample size calculation, 88 out of 135 studies mentioned rationales for setting the number of samples. Of which, 58 studies had statistical rationales. In many studies, the sample size calculation method that was commonly used in conventional PMSs, called ‘Rule of three’ was described as the statistical rational. After r-GPSP enacted, newly introduced Post-marketing surveillance, including DB surveys, and the scientific approach recommended by PMDA have been adopted in companies gradually. In the future, in order to further promote the scientific approach, it is necessary to further improve the capability of human resources of companies involved in PMS.