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Japanese to English: Non-Conformance and Improvements on Previous GLP Inspections. General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Japanese 30過去のGLP査察における指摘事項及び改善状況
改善が望ましい事項
(1)農薬GLP基準第6条第1項第2号に基づき、試験に従事する者は、逸脱の手続きについて標準操作手順書に従うこと。
改善状況
試験計画書からの軽微な逸脱については、逸脱書の作成はしないこと(なお、試験責任者は従来通りSOPに基づき逸脱内容及び試験成績への影響の評価について生データ及び最終報告書に記載する)を試験責任者の業務のSOP(SOP/試験責任者/Ol-01:平成19年2.月15日付け改訂)に記載した。
Translation - English 30. Non-Conformance and Improvements on Previous GLP Inspections.
Items recommended for improvement:
(1) People who are engaged in testing should comply with SOPs in regard to deviation procedures based on article 6, paragraph (1), item (2) of the pesticide GLP standard.
Improvements:
In regard to minor deviations from the testing plan, it was stated in the SOP for the study director duties (SOP/Testing Supervisor/01-01:2007/02/15 Revised) that a deviation report is not required (instead, the study director records the deviation details and the evaluation of the impact on the test results in the raw data and final report based on the usual SOP).
Japanese to English: 深部静脈血栓症 General field: Medical Detailed field: Medical: Health Care
Source text - Japanese 免疫性ヘパリン起因性血小板減少症に深部静脈血栓症を合併した患者で、ワーファリンとレピルジン等の直接的抗トロンビン剤の併用療法中に静脈性四肢壊疽を発症した症例2例を報告する。
Translation - English Two cases shall be reported in regards to the effects of direct thrombin inhibitors such as warfarin and refludan during therapy on patients with combined immune heparin-induced thrombocytopenia and deep vein thrombosis.
Japanese to English: 治験薬 General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Japanese 試験治療下で発現した消化器系の有害事象で最もよくみられたのは悪心・嘔吐で、発現率は10%であったが、全般に軽度であり治験薬の投与中止により回復した。
Translation - English The adverse effects on the digestive system for the medical treatment under development most commonly showed an incidence rate of 10% for nausea and vomiting, however there was recovery after discontinuation of generally mild concentrations of the investigational drug.
Japanese to English: 増配の承認 General field: Bus/Financial Detailed field: Management
Source text - Japanese 取締役会は、当社の財務状況が改善されたことを踏まえて下半期の配当を16%増と大幅な増配にすることを承認しました。これによって年間では24%の増配となります。今年度の売上は23%増、EPSは15%増となっています。
Translation - English The board of directors have approved a substantial 16% dividend increase for the second half of the financial year based on an improvement in the financial situation of the company. This will be a 24% dividend increase for the year. The current fiscal year has seen an increase in sales of 23% and an increase in EPS of 15%.
Japanese to English: Phase III trials General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Japanese 外国人データの利用について
申請者は、国際共同第III相試験で対象とした台湾人及び韓国人の成績を日本人の成績と併合して利用することが適切であると考える理由について以下の旨を説明した。
海外第I相試験及び国内第I相試験の結果、健康成人での日本人と外国人の薬物動態は類似しており、本剤のほとんどが未変化体のまま腎排泄されることが確認されていることから、本剤は民族差の影響を受けにくいと考える。また、国際共同第III相試験で得られた薬物動態成績では、臨床的に意味のある薬物動態の民族間の差が認められなかったことから、台湾人および韓国人の成績を利用することは可能であると考える。
Translation - English About the use of data for non-Japanese applicants.
The results of Taiwanese and Korean applicants who were targeted for the joint international phase III trial were combined with the results of Japanese applicants. The following justification is given as to why this use of data was deemed as appropriate.
The results of the international phase I trial and the domestic phase I trial as well as the pharmacokinetics of healthy non-Japanese and Japanese adults were similar. We think that the drug is unlikely to be affected by differences in ethnicity because it was confirmed that almost the entire drug is left unchanged after renal excretion. Also, the pharmacokinetic results obtained in the joint international phase III trial shows that it is possible to use results of Taiwanese and Korean people together because there was no pharmacokinetic difference of any clinical significance observed between these ethnicities.
Japanese to English: Software of the JXA-8230/8530F General field: Science Detailed field: Manufacturing
Source text - Japanese 本製品は，JXA－8230/8530Fで取得した分析データをオフラインで処理するためのプログラムです。
JXA－8230/8530Fと共通のユーザーインターフェイスで，ＥＰＭＡ本体のEPMAコントロールソフトと同等のデータ処理を行うことができます。
EPMA本体にエネルギー分散形X線分光器が構成されている場合は，EDS分析（単独）で取得したデータ，ED/WDコンバイン分析にて取得したEDSデータの処理も行うことができます。また，EDSアクティブマップで取得したデータからのEDSマップの再構成も可能です。分析データの他，電子像・X線像データの表示も可能です。
Translation - English This software is used for processing the acquired data by JXA-8230/8530F in off-line mode. You can perform the data processing equivalent to the one conducted by the EPMA control software of the instrument main unit by using the common user interface with the JXA-8230/8530F. When an energy dispersive X-ray spectrometer is configured in the EPMA main unit, you can also perform the processing of the data acquired by the (stand-alone) EDS analysis as well as the data acquired by the ED/WD combined analysis.
Moreover, it is also possible to reconstruct EDS maps from the data acquired using the EDS active map. It is also possible to display the electron image and X-ray image data other than the analysis data.
Japanese to English: RoHS指令（2002/95/EC） General field: Science Detailed field: Medical: Instruments
Source text - Japanese 構成国は、2013年1月2日までに、新たに採択されたRoHS指令（2011/65/EU）を国内法にすることが義務づけられており（25条1項）、その国内法化が完了する2013年1月2日までは、本指令が引き続き適用される。新しいRoHS指令（2011/65/EU）の採択により、本指令は、「RoHS I（ローズ ワン）」とも呼ばれる。
Member states have made the newly adopted RoHS directive (2011/65/EU) mandatory for inclusion in domestic law from January 2, 2013. This directive will continue to apply until January 2, 2013 when this directive becomes part of domestic law (article 25, section 1). From the adoption of the new RoHS (2011/65/EU), this directive will be referred to as “RoHS I (RoHS one)”.
The applicable electrical equipment are devices that are used at a rated voltage not exceeding an alternating current of 1000 V and a direct current of 1500 V. Applicable devices are determined in accordance with the WEEE directive and include 1. Large household appliances, 2. Small household appliances, 3. IT and telecommunications equipment, 4. Audio-visual equipment, 5. Lighting equipment, 6. Electrical and electronic tools, 7. Toys, leisure, and sports equipment, 10. Automatic dispensers, and fluorescent lamps. Essentially, all electrical and electronic equipment may be considered as applicable; however, spare parts that are used for repair or recycling of equipment sold prior to July 1, 2006 are exempt.
Member states are prohibited from using new equipment sold after July, 2006 that contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyl (PBB), and polybrominated diphenylether (PBDE). The use of these six substances is now prohibited due to design changes of equipment and alternatives use of substances. However, an exemption can be granted under a new condition if 1. Using alternative substances is technically or scientifically unfeasible, or 2. The negative impacts to the environment, health, and consumer from using the alternative substance outweigh its benefits. Member states must establish domestic law that enacts this directive before August 08, 2004 including penalties for non-compliance.
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Translation education
Bachelor's degree - Otago University
Experience
Years of experience: 21. Registered at ProZ.com: Oct 2009.
Extensive experience in the translation of operation manuals and procedures for electron microscopes, mass spectrometers, industrial equipment, medical devices, and other scientific instruments for leading Japanese manufacturers.
Numerous translations and proofreading of material safety data sheets (MSDS) for chemical substances.
Various laboratory reports that analyzed samples for microbiological, chemical, and physical hazards for laboratories throughout Japan and overseas.
Technical Information notification regarding upgrades, modifications or non-conformities in regard to scientific equipment.
Translation of audit reports for several major US pharmaceutical companies. Content includes ISO requirements, GMP requirements, legal requirements, and supplier requirements.
Translation of medical journals for the FDA and other medical institutions such as "The Journal of Japanese Respiratory Society", "The Allergy Journal", "The Journal of Therapy", and the "Japanese Journal of Dermatology" and reports for research institutions such as "The Tokyo Metropolitan Institute of Public Health".
Member of RAM Translations who specialize in medical and science related translations.
Quality Related Translations
Experience in the translation and proofreading of quality manuals, product specifications, and procedures for numerous manufacturers in Japan. I have extensive knowledge and practical experience regarding ISO standards and GMP concepts. Concepts include cleaning validation, process validation, analysis method validation, equipment qualification, document control, laboratory control, in-process control, distribution and warehousing, contamination control, risk management, statistical process control, six sigma concepts, cold chain storage, and other.
Translation of cause analysis reports and business letters in regards to customer complaints raised by overseas clients for a leading food manufacturer in Japan.
Translation of MSDS, HACCP and GMP related documents for pharmaceutical and food manufacturers.
Financial Related Translations
Ongoing 2 year translation project for a major Japanese tech company in regard to an upgrade of their computerized accounting systems including functions for Oracle and other internal systems.
On-site audit translations of accounting reports such as control testing and substantive testing, descriptions of internal controls, and descriptions of computer system functions of programs such as Oracle and Felix.
Accounting practices for Independent Administrative Institutions (IAI).
Various PowerPoint presentations used for business seminars and education.
Practical Experience Applicable to Translation
Lead Auditor for Quality and Food Safety Management Systems (ISO 9001 and 22000).
Lead Auditor for cGMP audits and technical reviewer of audit reports.
Performed over 100 quality and supplier audits for a variety of chemical, food, and pharmaceutical manufacturers in Japan for over 7 years.
Currently working in-house as a contracted translator with engineers at a leading Japanese manufacturer of scientific equipment. Duties include translation of manuals and technical information.
Qualifications
American Society for Quality (ASQ) ASQ-Certified Biomedical Auditor (CBA) (Cert. No. 1343)
International Register of Certificated Auditors (IRCA) Lead Auditor for Quality Management Systems (QMS) (Cert. No. 1188665).
Food Safety Lead Auditor Certificate (Certification no. 3040).
Bachelor of Commerce from Otago University, New Zealand.
In-house training on technical writing in accordance with The Microsoft Style Guide for Technical Publications and The Chicago Manual of Style.
Capable of using translation software and CAT tools such as SDL Trados Studio 2014 and Felix.
Expertise