Objective：To show that it is possible to capture pregnant women by identifying newborns and their mothers using JMDC database and examine a generalizability to Japan.

Methods：We identified a newborn who was born between 2016 and 2020 and his/her mother using health insurance association's registry owned by JMDC Inc. First, we identified a newborn whose relationship to the insured was “child” and who joined the health insurance association at birth month. And we linked a woman member aged 18 to 49 who belongs to the same family at the newborn's birth month to the newborn as a mother. We assessed a generalizability of these mothers and newborns obtained from this method by an age distribution of mother at birth month and proportion of newborn against women aged between 18 and 49 using Vital Statistics, National Census, and Population Estimates in Japan as index.

Results：We identified 194,036 mother-newborn pairs in JMDC database from 2016 to 2020. The mean mother's age at newborn's birth was 31.9. On the other hand, the number of births in Japan during the same period was 4,538,786, and the mean mothers' age was 31.5. Number of newborns per 1,000 women in JMDC database in 2020 was 19.0, and that in Japan was 37.0.

Conclusion：We concluded that our method of identifying pregnant women and newborns is useful for study of pregnant women and newborns.

Objective：To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future.

Design：Web based-questionnaire survey

Methods：This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18^th to February 14^th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer.

Results：［Background］ Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5％) have “experienced in utilization of RWD”, and 12 (11.8％) have “experienced in considering utilization of RWD”. ［Utilization by RWD Type］ By data source, hospital-based claim data was the most frequently used (65 cases, 63.7％), followed by insurance-based claim data (61 cases, 59.8％), surveys (38 cases, 37.3％), and EMR (36 cases, 35.3％) in experienced RWD utilization.

Conclusion：This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.