The Impact of the FDA GMP Regulation

1990 ◽  
Vol 9 (1) ◽  
pp. 105-106
Author(s):  
Robert N. Borghese

The impact of the Food and Drug Administration's Good Manufacturing Practice Regulation for Medical Devices is explored ten years after its promulgation. The main purpose of the regulation was never to be specific and exacting in interpretation, but rather to serve as a framework for the development of individualized quality assurance programs. The manufacturer is ultimatelly responsible for implementation. The role of the quality assurance professional is to be a persuasive advocator of compliance. Issues which were emphasized in the past are noted. What we can expect in the future is explored.

Author(s):  
Michael Adler

This chapter considers the future of administrative justice. Using the United Kingdom as a case study, it argues that the rise and fall of administrative justice can be likened to the swing of a pendulum. It considers first-instance decision-making, the role of outsourcing, the expanding role of administrative review and its implications for administrative justice, the decline of tribunals and the rise of ombudsmen, the effectiveness of oversight arrangements, and the impact of digitalisation. It concludes that the future of administrative justice in the United Kingdom is unlikely to involve a replay of anything that has been encountered in the past.


2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Pham Van Loi

Vietnam - Laos has more than 2,000 km of common national borders. The coherent relationship between the two nations and the inhabitants of the two countries has been formed and fostered in history and especially developed over the past 7 decades. The Thai ethnic group in Vietnam has over one million people, residing permanently, concentrated in the Northwest region, the region consists of 8 provinces, of which 4 provinces have the Vietnam-Laos border crossing. This paper focuses on clarifying the practical basis for the Thai people to play a role in the traditional Vietnam-Laos friendship and propose some solutions to promote the role of Thai in maintaining, developing the traditional friendship between Vietnam and Laos, now and in the future.


2017 ◽  
Vol 7 (2) ◽  
pp. 7-25
Author(s):  
Karolina Diallo

Pupil with Obsessive-Compulsive Disorder. Over the past twenty years childhood OCD has received more attention than any other anxiety disorder that occurs in the childhood. The increasing interest and research in this area have led to increasing number of diagnoses of OCD in children and adolescents, which affects both specialists and teachers. Depending on the severity of symptoms OCD has a detrimental effect upon child's school performance, which can lead almost to the impossibility to concentrate on school and associated duties. This article is devoted to the obsessive-compulsive disorder and its specifics in children, focusing on the impact of this disorder on behaviour, experience and performance of the child in the school environment. It mentions how important is the role of the teacher in whose class the pupil with this diagnosis is and it points out that it is necessary to increase teachers' competence to identify children with OCD symptoms, to take the disease into the account, to adapt the course of teaching and to introduce such measures that could help children reduce the anxiety and maintain (or increase) the school performance within and in accordance with the school regulations and curriculum.


Author(s):  
Paul Stevens

This chapter is concerned with the role of oil and gas in the economic development of the global economy. It focuses on the context in which established and newer oil and gas producers in developing countries must frame their policies to optimize the benefits of such resources. It outlines a history of the issue over the last twenty-five years. It considers oil and gas as factor inputs, their role in global trade, the role of oil prices in the macroeconomy and the impact of the geopolitics of oil and gas. It then considers various conventional views of the future of oil and gas in the primary energy mix. Finally, it challenges the drivers behind these conventional views of the future with an emphasis on why they may prove to be different from what is expected and how this may change the context in which producers must frame their policy responses.


Author(s):  
Donald Bloxham

Against majority opinion within his profession, Donald Bloxham argues that it is legitimate, often unavoidable, and frequently important for historians to make value judgements about the past. History and Morality draws on a wide range of historical examples, and its author’s insights as a practising historian. Examining concepts like impartiality, neutrality, contextualization, and the use and abuse of the idea of the past as a foreign country, Bloxham’s book investigates how the discipline has got to the point where what is preached can be so inconsistent with what is practised. It illuminates how far tacit moral judgements infuse works of history, and how strange those histories would look if the judgements were removed. Bloxham argues that rather than trying to eradicate all judgemental elements from their work historians need to think more consistently about how, and with what justification, they make the judgements that they do. The importance of all this lies not just in the responsibilities that historians bear towards the past—responsibilities to take historical actors on those actors’ own terms and to portray the impact of those actors’ deeds—but also in the role of history as a source of identity, pride, and shame in the present. The account of moral thought in History and Morality has ramifications far beyond the activities of vocational historians.


Author(s):  
Joelle H. Fong ◽  
Jackie Li

Abstract This paper examines the impact of uncertainties in the future trends of mortality on annuity values in Singapore's compulsory purchase market. We document persistent population mortality improvement trends over the past few decades, which underscores the importance of longevity risk in this market. Using the money's worth framework, we find that the life annuities delivered expected payouts valued at 1.019–1.185 (0.973–1.170) per dollar of annuity premium for males (females). Even in a low mortality improvement scenario, the annuities provide an expected value exceeding 0.950. This suggests that participants in the national annuity pool have access to attractively priced annuities, regardless of sex, product, and premium invested.


2021 ◽  
pp. 003329412110051
Author(s):  
Rashmi Gupta ◽  
Jemima Jacob ◽  
Gaurav Bansal

Psychosocial stressors and social disadvantages contribute to inequalities in opportunities and outcomes. In the current paper, we use an epidemiological perspective and highlight the role stress plays on individuals by reviewing the outcomes of major stressors such as poverty and unemployment. We further analyzed the psychological and physical cost of these stressors and their long-term impact. We examined the role of universal basic income and closely looked at income experiments that were implemented in the past, in terms of their effectiveness in enhancing the community as well as individual outcomes and propose the UBI as a tool for alleviating the impact of these stressors. At a time when a major pandemic (e.g., COVID-19) threatens economic stability and health globally, we believe the UBI is relevant now, more than ever.


Author(s):  
Teresa Lanzón Serra ◽  
Amelia Díaz Martínez

This work presents the evaluation of the stress symptoms associated to the task of caring for a dependent relative at home. The role played by variables such as type of caregiver (nurse/non-nurse), the relative dependency level, the number of hours per day dedicated to caring and the years the caregiver had been caring for the relative was studied. The sample was made up of 100 caregivers, and the variables associated to stress studied in the present work were intrusion, avoidance and activation. Results showed that non-nurse caregivers caring for a low dependency relative for a period of less than two years were those suffering a higher impact, with more symptoms associated to stress. Hours caring per day worked as a protective variable of stress, in that those caregivers dedicating a lower number of hours to caring had lower risk of suffering stress symptoms. These results clearly show the stressful impact of the first stages of dependency, even at the lowest level of dependency in a relative, on non-professional caregivers and highlight the need to provide strategies, similar to those shown by professional nurses looking after their own relatives, to reduce stress. This kind of intervention would prepare the caregiver for the future stages when the dependency level in the relatives and the effort caring for them would be higher.


2017 ◽  
Vol 12 (1) ◽  
pp. 39-57
Author(s):  
Jamie McKeown

This article reports the findings from a study of discursive representations of the future role of technology in the work of the US National Intelligence Council (NIC). Specifically, it investigates the interplay of ‘techno-optimism’ (a form of ideological bias) and propositional certainty in the NIC’s ‘Future Global Trends Reports’. In doing so, it answers the following questions: To what extent was techno-optimism present in the discourse? What level of propositional certainty was expressed in the discourse? How did the discourse deal with the inherent uncertainty of the future? Overall, the discourse was pronouncedly techno-optimist in its stance towards the future role of technology: high-technological solutions were portrayed as solving a host of problems, despite the readily available presence of low-technology or no-technology solutions. In all, 75.1% of the representations were presented as future categorical certainties, meaning the future was predominantly presented as a known and closed inevitability. The discourse dealt with the inherent uncertainty of the subject matter, that is, the future, by projecting the past and present into the future. This was particularly the case in relation to the idea of technological military dominance as a guarantee of global peace, and the role of technology as an inevitable force free from societal censorship.


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