Present Situation and Enlightenment of Post-Approval Change Management of Drugs in China,USA and EU

Objective To provide suggestions for further improvement of China’s drug post-approval change management system.Methods The current legal and regulatory requirements of post-approval change management systems of drugs in USA,EU and China were compared and analyzed.Results and Conclusion The post-approval change management of drugs is an important part of the whole life-cycle management of drugs.However,there are still some problems in China’s current post-approval change management systems.According to the model and requirements of the post-approval change management systems of the USA and EU,this paper proposes the following suggestions for the improvement of China’s post-approval change management system.Firstly,electronic files for licensed products should be created.Then,regulatory standards at the national level must be unified.Lastly,the concept of product life cycle management should be implemented.

Forces Driving Changes in Cultivated Land and Management Countermeasures in the Three Gorges Reservoir Area,China

The Three Gorges project accelerates economic development in the Three Gorges Reservoir Area.This paper aimed to investigate the distribution,changes and features of cultivated land in this area,analyze the forces driving the changes in cultivated land area,and propose the countermeasures for cultivated land management.Transition matrix was used to analyze the features of cultivated land changes,and quantitative analysis and qualitative analysis were adopted to research the driving forces according to the features of cultivated land changes.Cultivated land in the Three Gorges Reservoir Area mainly lay to the northwest of the Yangtze River,especially the upper reaches.The areas of cultivated land increased from 1996 to 1999,then decreased from 2000 to 2006,and finally increased again from 2007 to 2009.The important forces driving changes in cultivated land included government policies,employment and food security,increasing construction land,agriculture structure adjustment,land rearrangement,inundation.During cultivated land management,firstly,it is necessary to insist on the principle of cultivated land protection,standardize land exploitation and strictly restrict the transformation of cultivated land into non-farming land.Secondly,land rearrangement must be implemented,which can not only increase the area of the cultivated land,but also improve the quality of the cultivated land.Thirdly,it is feasible to intensify eco-agriculture construction to increase the quantity and quality of cultivated land.Fourthly,it is helpful to improve the traditional agriculture production methods to promote cultivated land quality.Lastly,it is important to propagandize cultivated land protection and realize the enormous pressure of cultivated land shortage,making more people obligated to protect cultivated land.

Characteristics of Organizational Leadership and Motivation as a Factor of Change in the Public Health System

The purpose of this study is to investigate the characteristics of organizational leaders in the health system and the factors that motivate health workers, in order to improve health care. The research was conducted in the public health institutions in Montenegro. The objectives of the research were to investigate whether leaders affect the motivation of employees in order to implement changes in the health system. The study was implemented through the interview method on the representative sample of 603 employees in public health institutions. The factor analysis revealed the latent characteristics of the organizational leader and the factors that motivate employees in public health institutions. The result of study indicates that employees in public health perceive organizational leadership to have a good quality. Result also exposes that the strongest motivation factor is a financial incentive. Financial incentive is the main motivator for employees in the public health sector, while the participation in decision-making was the least important motivational factor. The results obtained indicate that employees are primarily focused on individual goals, which influence the acceptance of change within the health system. The role of organizational leaders in motivating is poor because obtained factor scores are not correlated. The research has shown that organizational leaders do not have a great impact on the motivation of employees in the public health sector. This has effect on the process of accepting changes, where the roles of leaders are very important, especially in providing support to employees.

Engineering Change Management Adaptive to PLM

Engineering Change (EC) management for a Product Lifecycle Management (PLM) system, including EC data model, EC evaluation and EC implementation is presented. A method of dynamic and parallel EC evaluation is proposed, which breaks an EC evaluation task into several subtasks. Such subtasks can be dynamically and simultaneously proceeded, disassembled and communicated by different specialists, and at the same time a set of EC objects is created. This approach provides flexible and effective evaluation of the EC. The EC implementation followed will further ensure the completeness and consistency of EC data.

Beyond Transformational Change： Incremental Transformational Change in Institutions

Much has been written and researched about transformational change and the exogenous events that result in radical institutional transformation （Di Maggio ＆ Powell, 1983; Hannan＆ Freeman, 1989; Fligstein, 1996; Zorn, Dobbin, ＆ Kwok, 2006）. Accounts are provided of external agents disturbing the existing stasis of the institution and transforming the institution into something else that reflect a new paradigm or set of interests. Often, what is neglected in these accounts is what fractures exist in the original institution that would make them vulnerable and allow penetration by exogenous influences. Mahoney and Thelen （20 l 0） went beyond a general model of change that described the collapse of one set of institutional norms to be replaced by another. The model of change they propose takes into account both exogenous as well as endogenous factors as being the source of institutional change. They went on to state a view that transformation change as being a result of abrupt, wholesale breakdown needs to be rethought to include incremental, endogenous shifts in thinking that can often result in fundamental transformations.

The Impact of Temporal and Political Context on Institutional Change

In order to gain a more comprehensive understanding of institutional change, researchers need to go beyond a snapshot view of significant events but consider events in their temporal setting. Pierson （2004） advocated that the events that lead to institutional change should be placed in a moving temporal context, as this will not only add to our comprehension of the dynamics of change, but also enrich the existing research and enhance the theories we employ to give meaning to these events. Pierson （2004） laid the foundation for the research that was later developed by Thelen （2009） that considered incremental endogenous shifts in institutional thinking that can often result in fundamental transformations. The central issues of Pierson＇s （2004） thesis lay in his interpretation of history and its relationship with path dependence. He claimed that once an institution has chosen a particular path to follow, it can become locked into that pathway and so the options of choice are restricted. This then presumed that an institutions first choice of action is crucial to whether they become locked into a successful course of action or not. The result of the first choice being successful or not would be dependent on the presence of increasing returns. The explication Pierson proffers of increasing returns is different to an economic one in that it is based on positive feedback processes and politics in time. The implications of Pierson＇s work and those that followed have a very serious place in our understanding of institutional change.

“Integrating OD, HR and Change Management: Strategies for Sustained Success”--Insights on AODN and Foresights on Application of OD to Educational Systems

Organizations are facing unprecedented challenges in the 21st century and OD plays a significant role in creating effective responses to these changes.Not only has it been applied in the USA but gains popularity in dynamic Asian region under the megatrend of globalization and information technology.This paper gains insight from Asia Organization Development(OD)Network Summit and discusses future potential application of OD to educational systems.

An Exploratory Study of University X＇s State of Readiness： Scholarship of Teaching, Shared Governance and Change Management

In this paper we first explore what scholarship of teaching （SOT）, shared governance and change management means, both in terms of the way that is represented in the literature and the way that is understood by academic staff themselves. From this information we derive qualitative and quantitative interpretation which captures the variations found in the literature and empirical studies. In the final section we illustrate how the state of readiness in the three areas is in place for the development of the SoT, shared governance, and change management in University X.

Study on Management Accounting Change Management and Innovation

At present, China has entered a new normal mode of economy; change management is a very important path of advancing management accounting to keep pace with the times. Obviously, management accounting change usually does not develop along with the established track, and it only relies on its own power to be completed and is executed only through change management. In this paper, management accounting change management and innovation are studied, expecting to play a role in promoting other scholars to join this study.

Effect on greenhouse gas balance of converting rice paddies to vegetable production

Rice paddies are increasingly being converted to vegetable production due to economic benefits related,in part,to changes in demand during recent decades.Here,we implemented a parallel field experiment to simultaneously measure annual emissions of CH_4and N_2O,and soil organic carbon(SOC)stock changes,in rice paddies(RP),rice paddy–converted conventional vegetable fields(CV),and rice paddy–converted greenhouse vegetable fields(GV).Changing from rice to vegetable production reduced CH_4emissions by nearly 100%,and also triggered substantial N_2O emissions.Furthermore,annual N_2O emissions from GV significantly exceeded those from CV due to lower soil p H and higher soil temperature.Marginal SOC losses occurred after one year of cultivation of RP,CV,and GV,contributing an important share(3.4%,32.2%,and 10.3%,respectively)of the overall global warming potential(GWP)balance.The decline in CH_4emissions outweighed the increased N_2O emissions and SOC losses in CV and GV,leading to a 13%–30%reduction in annual GWP as compared to RP.These results suggest that large-scale expansion of vegetable production at the expense of rice paddies is beneficial for mitigating climate change in terms of the overall GWP.

Is transesophageal echocardiography needed for evaluating tissue-based transient ischemic attack？

Transient ischemic attack（TIA） is a warning signal for stroke.A comprehensive evaluation of TIA may reduce the risk for subsequent stroke.Data on the findings of cardiac evaluation with transesophageal echocardiography（TEE） in patients with TIA are sparse.Our aims were to determine the frequency of TEE performance and to investigate the findings of TEE in patients with TIA based on the new definition of TIA（i.e.,transient neurological symptoms without evidence of infarction）.During a 4-year period（2011–2014）,1071 patients（mean age,70 ± 13 years;female,49.7%） with TIA were included in a prospective study and evaluated.Of 1071 consecutive patients suffering from TIA,288 patients（27%） underwent TEE.The median time between admission and TEE was 6 days.Patients with TIA who were evaluated by TEE were younger（67 vs.71 years,P 〈 0.001） than those who were not evaluated by TEE.They had a higher rate of sensibility disturbance as a TIA symptom（39% vs.31%,P = 0.012） but a lower rate of previous stroke（15% vs.25%,P = 0.001） and atrial fibrillation（2% vs.21%,P 〈 0.001） than those who did not.Foramen ovale was detected in 71 patients（25.7%）,atrial septal aneurysm in 13 patients（4.6%）,and severe atherosclerotic plaques（grade 4 and 5） in the aortic arch in 25 patients（8.7%）.One patient（0.3%） had a fibroma detected by TEE.In 17 of the 288 patients（6%） who underwent TEE,the indication for anticoagulation therapy was based on the TEE results,and 1 patient with fibroma underwent heart surgery.During hospitalization,7 patients experienced a subsequent stroke,and 27 patients had a recurrent TIA.At 3 months following discharge,the rates of readmission,stroke,recurrent TIA,and death were 19%,2.7%,4.2%,and 1.6%,respectively.The rates of mortality（0.9% vs.1.8%,P = 0.7）,stroke risk（1.9% vs.3.0%,P = 0.8）,and recurrent TIA（5.0% vs.3.9%,P = 0.8） were similar in patients who underwent TEE and in those who did not.Performing TEE in patients with tissue-based TIA is helpful in detecting cardiac sources for embolism and may indicate for anticoagulation.

The Role of Cooperative Strategies in Destinations＇ Competitiveness in a Turbulent Environment

Destination management is a key issue of all overall models of destinations＇ competitiveness and seems to be a ＂panacea＂ in those countries, which introduces the tool-system in the near past, so as to support the destinations （national/regional or local level） to keep up with keen competition, mainly in the Central-Eastern and Balkan region. The culture of cooperation holds difficulties in this region. The lack of trust as well as cooperation in bigger groups can be drawn back to the distrust business culture typical in these countries, and the so-called group collectivism （a phenomenon of building trust in small groups based on personal contacts）. The main focus of this paper is to summarize the theoretical approaches to destinations＇ competitiveness and destination management and to summarize the results of two case studies concerning a destination facing keen competition or escaping from a decline. The main research question is： ＂What kind of role can （could） destination management play in destinations＇ competitiveness in a turbulent environment？＂. As a result of this research, the differentiated analysis of management-oriented view of destinations＇ competitiveness was carried out, as well as crystallizing the key success/failure factors of destination management.

Partnering Together to Reduce Sepsis Mortality： A Novel Approach

Each year 750,000 Americans are diagnosed with sepsis and approximately 220,000 of those patients die. In addition to the toll on human life, sepsis is the most expensive disease to care for in the hospital costing approximately 17 billion dollars annually. National and international initiatives have demonstrated the benefits of recognition, early fluid resuscitation and broad spectrum antibiotics to reduce sepsis mortality. The Surviving Sepsis Campaign recently issued the third iteration of clinical bundles for the management of severe sepsis and septic shock. Robust Process Improvement （RPITM） which integrates the principles of Six Sigma, Lean and Change Management was applied to increase overall compliance to implement the elements of the three hour sepsis bundle in a complex healthcare system. The elements of the three hour sepsis bundle are drawing blood cultures before ordering antibiotics, timely antibiotic administration, obtaining lactate and administering fluid bolus. It has been demonstrated for severe sepsis and septic shock that bundle compliance is associated with a reduction in hospital mortality. The results of this study indicated that the overall bundle compliance increased by 30% which resulted in reducing the sepsis mortality rate by 27%.

A Review of Institutional Reform over the Past 30 Years from the Perspective of Change Management

The Leading Group for Deepening Reform Comprehensively has been set up on the decision of the CPC Central Committee to be in charge of the overall planning of reform, taking a balanced and coordinated approach, advancing reform as a whole and supervising its implementation. This means that change management has become an important item on the agenda. Systematically reviewing and examining the course of the seven rounds of institutional reform introduced by the State Council since 1978 from the perspective of change management, we find that the reforms have advanced gradually and steadily, with functional transformation as the core feature and key to each round of reform. The transformation of goverrnnent functions exhibits a marked two-phase character. The first phase focuses on change in government functions relating to economic management, while the second focuses on enhancing and improving macro-control systems to strengthen social management and public service functions. However, in terms of program design, the goalsand measures of the past 10 years＇ functional transformation have clearly not been specific enough to establish a clear relationship between the three rounds of institutional reform programs and the concrete measures and their effects. Therefore, the question of whether institutional reform itself needs reform has become a new proposition for practice, one that needs to be reviewed in terms of strategic orientation, mode of implementation, public responsibilities and overall design.

A Benefit Measurement Framework for an Online Contract Change Management System

The contract change management (CCM) system is an online collaboration tool, which supports the contract change management process of new engineering contract (NEC) contract. It is currently used in practice on a wide range of civil, power, and building projects in the UK. The aim of this study is first to identify the tangible and intangible benefits of the system through a user survey; then to develop a framework to measure these benefits. A questionnaire survey is conducted, which reveals that CCM can help project teams improve process effectiveness, reduce risk of process failures, and increase the compliance with NEC requirements. Subsequently, a spreadsheet tool is developed to allow CCM users to calculate the tangible cost savings as a result of using the system. For intangible benefits, a change management maturity model (CM3) is developed, which provides a measurement framework for assessing the improvement of a project team’s capability in dealing with contract changes.

Model server enabled management of collaborative changes in building information models

The issues and challenges involved in controlling the collaborative changes in a Building Information Modeling(BIM) data repository, in a multi-model collaboration environment, are discussed. It is suggested that managing iterative changes in BIMs is a database problem, exacerbated by the long transaction times needed to support collaborative design progression. This is yet to be resolved in the construction industry and better solutions are needed to support the underlying workflows and computing operations for seamless collaboration on BIMs. With this in mind, this paper proposes the use of the structural and semantic characteristics of BIM objects as a mechanism for tracking changes across co-developed solutions. The creation of object signatures, using hash codes derived from their characteristics, provides a potential mechanism for object comparison and effective change recognition and management.

Empirical Test for Earnings Management of Top Managers＇ Change in Listed Companies

Top managers play a significant role on business decision in listed companies. The frequency of top managers＇ change is rather high all along. Whether those listed companies which top managers changed can really improve performances？ In this paper, we will discuss whether listed companies improve the financial index through earning management and give some advice on top managers＇ change in listed companies in China.

AI,the internet of legal things,and lawyers

A great deal of has been written about the challenges of a legal profession that resists change and sub-optimizes clients’benefits,and even more ink has been spilled on the opportunities and threats of AI.As laws are falling further behind an accelerating,dynamic world,the gap between businesses and opaque legal functions widens with the latter being perceived often as fire-fighting cost centers.This article calls out the opportunity of AI,specifically machine learning,and its impact on decision making as an opportunity for business leaders to elevate lawyers to contribute further to corporate strategies and operations.Surveying the implications of machine learning through the lens of each element of decision making,the article aims to bring the relevance of today’s ubiquitous transformations to the legal function.It also reminds business leaders that the legal function will need some help,such as corporate legal strategists,to drive and sustain change that resides in the intersection of law,business and technology.