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.

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.

“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.

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.

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.

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.