The Self-inspections(Internal Audits)Process as a Part of the Pharmaceutical Quality System:Formation of a Risk-Based Approach to Internal Audits Planning

The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.

The application of internal suspension technique in retroperitoneal robot-assisted laparoscopic partial nephrectomy with a new robotic system KangDuo Surgical Robot-01:Initial experience

Objective To assess the feasibility of internal suspension technique in retroperitoneal robot-assisted laparoscopic partial nephrectomy(rRAPN)with a new robotic platform called KangDuo Surgical Robot-01(KD-SR-01)system(Suzhou KangDuo Robot Co.,Ltd.,Suzhou,China)and discuss its surgical technique.Methods A 44-year-old male patient was admitted with a 2.5 cm tumor on dorsolateral upper pole of the left kidney.The R.E.N.A.L.nephrometry score of this patient was 4x.This patient underwent rRAPN with KD-SR-01.The perinephric fat between the tumor and Gerota's fascia was preserved,which was used for internal suspension traction during tumor resection.Postoperative follow-up data were collected.Results The surgery was successfully carried out with a duration of 127 min,in which the docking time was 6 min 25 s and console time was 60 min.The warm ischemia time was 19 min 53 s,and the estimated blood loss was 0 mL.The pathological histology showed a pathological tumor stage 1a clear cell renal cell carcinoma,with a negative surgical margin.The World Health Organization/International Society of Urological Pathology(WHO/ISUP)grade of this patient was Grade 2.No recurrence was observed during the 6-month follow-up.Conclusion Internal suspension in rRAPN is feasible and effective with use of the new robotic system KD-SR-01.

On Translation Approaches of International Treaties from English to Chinese-A Case Study of CISG

With the acceleration of the process of globalization and the more important role China is playing on international stage,both our economic systems and our notions of right and system of law should and had to be improved to attune to new conditions.In this process,many laws and customs including international treaties need to be translated from English to Chinese to make it convenient for scholars,researchers and legal workers and practitioners in law to study and practice.However,theoretical research on legal translation,especially from the perspective of standards of the translation of treaties,still lags behind.

Teaching“International Business Contracts”Based on Production-Oriented Approach

Production-Oriented Approach(POA)is a new concept of foreign language teaching proposed by Professor Wen Qiufang of Bejing Foreign Studies University.Initially designed for teaching foreign languages in lower grades in domestic universities,its application has now been gradually expanded to more subjects and has been repeatedly proven to be effective after active experiments by some university teachers.In this paper,the author attempts to apply the production-oriented method to the teaching of intemational business contracts,and take one of the units as an example to demonstrate the teaching design and teaching process.

Contribution of International and Comparative Approach to the Policy and Practice of Teacher Education

This study intends to identify the value and pitfalls of international and comparative approach for the policy and practice of teacher education.The structure of this article proceeds as follows:the first section focuses on explaining the meaning and the values of international and comparative approach;based on previous discussions,the second section makes a more in-depth analysis of the values of international and comparative approach to teacher education from five key themes;the final section of this article proposes and interprets the drawbacks of international and comparative approach in teacher education.

Based on the Features of E-Approach and I-Approach Discuss and Analyze the SLA

Externalized approach and Internalized approach are two approaches to the study of languages. Understanding the features of two approaches is indispensable to discuss and analyze the acquisition of second language. And universal grammar which is closely related to the two approaches plays an important role in the acquisition of second language. Three accesses to universal grammar in L2 learning are explicitly described to state the second language is acquired.

An overview on the distributed internal model approach and its applications

The cooperative output regulation problem has been studied by two approaches:the distributed observer(DO)approach and the distributed internal model(DIM)approach,respectively.Each of these two approaches has its own merits and weaknesses.Recently,we presented an overview on the cooperative output regulation problem by the DO approach.This paper further surveys the cooperative output regulation problem by the DIM approach.We first summarize the constructions and the roles of two different versions of the internal models:the distributed p-copy internal model and the distributed canonical internal model.Then,we describe an integrated framework that combines the DO approach and the DIM approach.Extensions and variants of the DIM and their applications will also be highlighted.

International carbon markets under the Paris Agreement:Basic form and development prospects

Article 6 of the Paris Agreement introduces two international carbon markets that receive extensive attention and are expected to play an important role in the post-2020 climate regime.Three key elements of the two international carbon markets,including the scope,the types of tradable units and the governance,are identified,as the basis to clarify their basic forms.Based on the key issues and their different designs identified in negotiations,this study analyzes the contributions and challenges for China to participate in international carbon markets.Considering the inherent needs of climate change mitigation,climate finance,the development of a green"Belt and Road"and the China South-South cooperation in climate change,along with the existing domestic capacities on market mechanisms,this study puts forward the short-,medium-and long-term development prospects of the two international carbon markets.

Approach Choice and Innovative Model Design of Grass-root Agricultural Technology Promotion under the View of New Countryside

This paper introduces the approach types of agricultural technology promotion we can choose in the process of new countryside construction, and there are mainly 6 types, namely government-domination-oriented approach, market-development-oriented approach, university (scientific research institution)-education-oriented approach, farmers' participation-oriented approach, direct-training-oriented approach and individual-service-oriented approach, including 20 models. The problems existing in the grass-root agricultural technology promotion in the process of new village construction are analyzed as follows: the awareness of innovation is not strong; scientific research, education, and promotion are disjointed; the construction of specific work system lags behind; the structure of promotion team is irrational, and the quality of promotion personnel is yet to be promoted; the cultural quality of farmers is low, and the cooperative organizations are not sound; the working conditions are poor, and the basic security is inadequate; the investment channel is simple and the supply amount is badly short; the methods of agricultural technology promotion do not adapt to the requirements of new situation. According to the characteristics and internal requirements of grass-root agricultural technology promotion, we creatively design an overall working model, and put forward new measures from objective of grass-root agricultural technology promotion, service object, service content, organization work and scope, method, role of agricultural technology personnel and so on.

Quadrilateral plate fractures of the acetabulum:Classification,approach,implant therapy and related research progress

The quadrilateral plate(QP)is an essential structure of the inner wall of the acetabulum,an important weight-bearing joint of the human body,which is often involved in acetabular fractures.The operative exposure,reduction and fixation of QP fractures have always been the difficulties in orthopedics due to the special morphological structure and anatomical features of the QP.Fortunately,there have been many effective methods and instruments developed for QP exposure,reduction and fixation by virtue of the combined efforts of numerous orthopedists.At the same time,each method presents with its own advantages and disadvantages,resulting in different prognoses.It is necessary to have a thorough understanding of the anatomy,radiology and fixation techniques of the QP in terms of patient prognosis optimization.In this paper,the anatomical features,definition and classification of QP,operative approach selection,implant internal fixation methods and efficacy were reviewed.

International Private Sector Participation in Water Governance in China under CEWP in the Future

Water utility is considered as unique among all the natural monopolies. Overseas private sector involvement in water utility operation has been always being a sensitive topic in China. Overseas investment and engagement has happened progressively in spite of implicit and explicit barriers within China. Reviewing past foreign investments in water supply and sanitation in China, experiences and lessons co-existed, based on the combined analysis both concerning the past practices and current new possibilities, the future cooperation on international private sector participation can be looked forward to.

A Comparative Analysis of the Regulatory Approaches to Personal Data between the EU and the US

The regulatory approaches of the EU and the US in the realm of personal data remain to be studied.This article analyzes regulatory approaches of the two digital economy giants from a comparative perspective.It finds that even though huge divergences exist in the substantive rules of personal data protection between the EU and the US,they share the de facto common strategies that have been applied to the regulation.In particular,the regulation focus of personal data has been shifted to the internal data protection systems of private sectors.For regulators,collaborative governance and contextual approaches are the preference in comparison with traditional top-down regulation.On this basis,this article analyzes the current regulatory approaches of the EU and the US.As articulated by Ari Ezra Waldman,the shift of regulatory approaches can be categorized as a“second wave of privacy law.”This article also points out the potential pitfalls the current approaches may fall into.

Kuhnian Understanding of Incommensurability and Implications of Paradigmatic Conception of Knowledge in International Relations

In international relations theory （maybe more than in any other discipline of social sciences）, the paradigmatic construction of Thomas Kuhn and his model of incommensurability might be applied to the theoretical interpretation of phenomena; and it is one of the cornerstones of the methodological toolkit for the interpretation in this field. The paper explores the reason why Kuhn＇s understanding of incommensurability seems to be necessary for the conception of knowledge in international relations： the concept of incommensurability can be considered typical as it is meant to indicate a conflict, of one form or another, between theories. And the discipline of international relations is more than a perfect ground for considering this concept when one is having in mind the high degree of polarized debate among rivalry theoretical schools （for interpreting and describing the identical phenomena） that is present from the very beginning of the discipline. Recalling the Kuhnian conception of science in paradigmatic view with an aim for understanding--international relations theory, the paper analyzes furthermore his rejection of the traditional dichotomy between “objectivisn”and ＂subjectivism.＂

Comparison of two surgical approaches for petroclinic lesions

Objective:to compare the methods of petrous apical bone removal and to explore the applicable scope of Kawase approach and retrosigmoid sinus-internal auditory canal approach.Methods:one group of cadaveric head specimens simulated Kawase approach to measure the data of“Kawase triangle”,the other group simulated retrosigmoid sinus-internal auditory canal approach to measure the safety range of the grinding bone window.Then we explored the clinical indications of the two surgical approaches.Result:the grinding depth of Kawase triangle was 11.6±0.14 mm,and the range of clival exposed after grinding Kawase triangle was 22.4±1.22 mm,which could effectively expose the ventrolateral brainstem,the midline of clivus and the area above the facial acoustic nerve.The diameter of the anterior and posterior of the grinding bone window in the retrosigmoid sinus-internal auditory canal approach was 21.95±2.23 mm.In front of the exposure area were the internal carotid artery,the cavernous sinus,and the upper trigeminal nerve;the lower part was the connection between the facial acoustic nerve and the abducent nerve.Conclusion:Kawase approach is suitable for lesions of ventrolateral brainstem,middle superior clivus,with or without invasion of middle cranial fossa;the retrosigmoid sinus-superior internal auditory canal approach is suitable for lesions mainly in cerebellopontine angle area and only slightly invading Meckel’s cavity.

3D打印技术在腓骨头上入路治疗复杂胫骨平台后外侧骨折中的临床应用

目的探讨3D打印技术在腓骨头上入路治疗复杂胫骨平台后外侧骨折中的临床应用价值。方法回顾性分析67例接受腓骨头上入路治疗的复杂胫骨平台后外侧骨折患者的临床资料,根据术前是否采用3D打印模拟手术将患者分为3D打印组35例和常规组32例。比较2组患者的手术时间、术中出血量、术中透视次数,观察术后切口感染、腘血管损伤、腓总神经损伤等并发症发生情况。随访骨折愈合时间,术后6个月评估Rasmussen评分,末次随访时评估美国特种外科医院(HSS)膝关节功能评分。结果67例患者随访时间为14~22个月;2组各有1例患者发生术后切口感染,均未发生腘血管损伤、腓总神经损伤、下肢深静脉血栓等并发症;3D打印组患者手术时间、术中出血量、术中透视次数均短于或少于常规组,差异有统计学意义(P<0.05);2组患者骨折愈合时间、术后6个月Rasmussen评分、末次随访时HSS评分比较,差异无统计学意义(P>0.05)。结论3D打印技术应用于复杂胫骨平台后外侧骨折患者的腓骨头上入路治疗中,可以优化手术方案,缩短手术时间,减少术中出血量和透视次数。

新时代“翻译+国际传播”融合型文学翻译人才培养研究:概念、内涵与路径

新的历史时期,随着我国综合国力和国际地位的提升,亟需提升文化软实力,“自塑”中国形象,传播中国声音。这对文学翻译人才培养提出了新要求,人才培养模式亟需创新。新时代,文学翻译人才培养应实现从翻译到“翻译+国际传播”的转变,以提升中国思想的国际传播效能。本文认为,树立翻译与国际传播交叉融合的教学理念、科学设置人才培养方案、加强复合型师资队伍建设、加强翻译人才全要素教学是培养“翻译+国际传播”融合型文学翻译人才培养的有效路径。

新型举国体制推动军民科技协同创新:内在逻辑与实践进路

新型举国体制是传统举国体制在新时代的适应性转型,在国家竞争日益加剧和民族复兴的关键时期,新型举国体制成为发挥中国制度优势、破解关键核心技术难题、实现国家战略任务的重要抓手。如何探索新型举国体制的实现方式,尤其是在国家安全、军民融合等重大战略领域满足国家战略需求,已成为当前亟需回答的重要课题。鉴于此,在深入分析新型举国体制推动军民科技协同创新的内在逻辑及创新要素基础上,从组织体系及实现机制两个层面构建新型举国体制推动军民科技协同创新的分析框架,并通过对军民协同推进新冠疫苗研发的全景式回顾进行案例探索,揭示新冠疫苗研发的中国经验——以新型举国体制为制度优势,以定位“国家重大战略任务”为前提,在党中央集中统一领导下,发挥军民融合的战略支撑作用,释放社会主义市场经济活力的中国方式。

经跟腱旁入路切开复位内固定治疗后踝夹心形骨折

背景:踝关节骨折直视下精准复位已经成为足踝外科医生的共识,如何充分显露后踝的游离或压缩骨折块,仍然是具有挑战性的难题之一。目的:探讨经跟腱旁入路切开复位内固定治疗后踝夹心形骨折的临床疗效。方法:回顾性分析2020年1-12月大连市第二人民医院收治的26例后踝夹心形骨折患者的临床资料,均采用经跟腱旁入路切开复位内固定治疗,其中经跟腱外侧入路21例,经跟腱内侧入路5例;男19例,女7例;年龄24-69岁,平均38.6岁。记录手术时间,观察术后并发症情况;通过Burwell-Charnley影像学标准评价骨折复位情况;记录术前、术后3个月及末次随访时目测类比评分、踝关节跖屈及背伸活动度和美国足踝外科协会踝-后足功能评分,评估临床效果。结果与结论:(1)26例患者均获随访,随访时间13-18个月,平均14.6个月;手术时间52-85 min,平均64.2 min;(2)1例患者术后外踝切口部分皮缘坏死,通过换药后完全愈合;其余患者手术切口均Ⅰ期愈合;(3)Burwell-Charnley影像学标准评价:24例解剖复位,2例复位良好,优良率为100%;(4)末次随访时目测类比评分为(1.19±0.40)分,较术前(6.81±0.80)分明显下降(P<0.01);末次随访时踝关节跖屈为(33.5±5.02)°,踝关节背伸为(17.23±0.99)°,较术前(14.58±2.50)°、(5.81±1.02)°均明显增加(P<0.01);美国足踝外科协会踝-后足功能评分为(89.31±3.62)分,较术前(46.00±5.45)分明显升高(P<0.01);其中优23例,良3例,优良率为100%;(5)提示经跟腱旁入路切开复位内固定治疗后踝夹心形骨折手术时间短,骨折复位良好,并发症少,关节活动度及功能恢复满意。

国际承包商合规体系的有效性度量研究

为响应廉洁“一带一路”号召,助力国际承包商开展有效的合规管理,采用文献分析法、德尔菲法构建企业层面的合规指标体系,并基于Fuzzy-OPA形成合规体系的有效性度量模型,通过调研某国际承包商的合规体系验证模型的合理性。研究结果表明:合规指标体系包含合规准则、措施及最佳实践,基于Fuzzy-OPA构建的度量模型能够评价企业合规体系的有效性,为诊断合规薄弱环节、完善合规体系提供参考。

椎旁肌间隙入路椎弓根螺钉内固定结合伤椎置钉方案对脊柱骨折患者伤椎恢复及疼痛的影响

目的探究椎旁肌间隙入路椎弓根螺钉内固定结合伤椎置钉方案对脊柱骨折患者伤椎恢复及疼痛的影响。方法选取首都医科大学附属北京安贞医院2021年5月至2023年5月收治的50例脊柱骨折患者。采用抽签法将患者分为对照组和观察组,各25例。对照组采用棘突旁入路椎弓根螺钉内固定联合伤椎置钉治疗;观察组采用椎旁肌间隙入路椎弓根螺钉内固定结合伤椎置钉治疗。比较2组围手术期指标、疼痛度、椎体前缘高度改善状况、Cobb′s角、血清骨代谢指标水平、创伤因子水平。结果观察组术中出血量、手术时间、术后卧床时间、术后引流量、术后住院时间均少于/短于对照组,术后3 d疼痛视觉模拟量表评分低于对照组(均P<0.001)。术后3 d、3个月,观察组椎体前缘高度[(14.0±1.3)cm比(11.7±1.2)cm、(15.4±1.7)cm比(12.8±1.3)cm]、Ⅰ型前胶原氨基端前肽水平均高于对照组,Cobb′s角均小于对照组、Ⅰ型胶原羧基末端肽水平均低于对照组(均P<0.001)。术后3 d,观察组肌红蛋白、乳酸脱氢酶、肌酸激酶水平均低于对照组(均P<0.05)。结论椎弓根螺钉内固定结合伤椎置钉方案中使用椎旁肌间隙入路临床疗效更佳,具有手术切口小、时间短和恢复快的特征,且有助于患者伤椎恢复,减少疼痛,促进骨愈合。