A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.
1．Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities
2．How to select Safety Specification (SS) and describe its characteristics
・Selection of SS
・Characterization of SS
・Association with Research Questions (RQ)
3．How to define and describe RQ
・What is RQ ?
・RQ interpretation in other relevant guidelines
・Methodology to develop RQ for PVP with examples
・Best approach to integrating PVP for whole aspects of safety concern
4．How to optimize PVP for specific RQ
・Routine PVP or additional PVP ?
・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)
・Checklist to help develop PVP
5．Epilogue:
・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.
・Significance of background incidence rate and needs for comparator group
・Infrastructure for the future PVP activities
6．Appendix: Checklist to help develop PVP activities in RMP
The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.

Background/Aims: There are few published registry studies from Asia on pediatric inflammatory bowel disease (IBD). Registry network data enable comparisons among ethnic groups. This study examined the characteristics of IBD in Japanese children and compared them with those in European children. Methods: This was a cross-sectional multicenter registry study of newly diagnosed Japanese pediatric IBD patients. The Paris classification was used to categorize IBD features, and results were compared with published EUROKIDS data. Results: A total of 265 pediatric IBD patients were initially registered, with 22 later excluded for having incomplete demographic data. For the analysis, 91 Crohn’s disease (CD), 146 ulcerative colitis (UC), and 6 IBD-unclassified cases were eligible. For age at diagnosis, 20.9% of CD, 21.9% of UC, and 83.3% of IBD-unclassified cases were diagnosed before age 10 years. For CD location, 18.7%, 13.2%, 64.8%, 47.3%, and 20.9% were classified as involving L1 (ileocecum), L2 (colon), L3 (ileocolon), L4a (esophagus/stomach/duodenum), and L4b (jejunum/proximal ileum), respectively. For UC extent, 76% were classified as E4 (pancolitis). For CD behavior, B1 (non-stricturingon-penetrating), B2 (stricturing), B3 (penetrating), and B2B3 were seen in 83.5%, 11.0%, 3.3%, and 2.2%, respectively. A comparison between Japanese and European children showed less L2 involvement (13.2% vs. 27.3%, P< 0.01) but more L4a (47.3% vs. 29.6%, P< 0.01) and L3 (64.8% vs. 52.7%, P< 0.05) involvement in Japanese CD children. Pediatric perianal CD was more prevalent in Japanese children (34.1% vs. 9.7%, P< 0.01). Conclusions Upper gastrointestinal and perianal CD lesions are more common in Japanese children than in European children.

Objective：The English version of the Characterizing Freezing of Gait questionnaire (C-FOGQ) that is used to assess detailed information of freezing of gait was developed by Ehgoetz Martens et al. This study aims to develop the Japanese version of the C-FOGQ using guidelines for cross-cultural adaptation and to conduct the pretesting study.Methods：The C-FOGQ was translated with permission into Japanese according to the following guidelines for cross-cultural adaptation： (1) translation (English to Japanese), (2) back-translation (Japanese to English), and (3) pretesting. Thirty-nine patients with parkinsonism-related disorders participated in the pretesting study.Results：There was no significant linguistic problem in the process of translation and back-translation. In pretesting, the average response time of the Japanese version of the C-FOGQ was 526.8 seconds. The error/no-response rate was less than 1%. The average score for section II of the Japanese version of the C-FOGQ was 20.0 points.Conclusion：A linguistically-validated Japanese version of the FOGQ was developed according to the guidelines of cross-cultural adaptation. It seems to be possible to use this questionnaire for detailed evaluation of gait freezing in Japan as well as in the West.

Objective：The English version of the Characterizing Freezing of Gait questionnaire (C-FOGQ) that is used to assess detailed information of freezing of gait was developed by Ehgoetz Martens et al. This study aims to develop the Japanese version of the C-FOGQ using guidelines for cross-cultural adaptation and to conduct the pretesting study.Methods：The C-FOGQ was translated with permission into Japanese according to the following guidelines for cross-cultural adaptation：(1) translation (English to Japanese), (2) back-translation (Japanese to English), and (3) pretesting. Thirty-nine patients with parkinsonism-related disorders participated in the pretesting study.Results：There was no significant linguistic problem in the process of translation and back-translation. In pretesting, the average response time of the Japanese version of the C-FOGQ was 526.8 seconds. The error/no-response rate was less than 1%. The average score for section II of the Japanese version of the C-FOGQ was 20.0 points.Conclusion：A linguistically-validated Japanese version of the FOGQ was developed according to the guidelines of cross-cultural adaptation. It seems to be possible to use this questionnaire for detailed evaluation of gait freezing in Japan as well as in the West.