Die Sicherheitsphilosophie bei der Entwicklung neuer Arzneimittel besteht in einer individuellen Prüfung der sicherheitsrelevanten Eigenschaften neuer Substanzen und ist durch das Arzneimittelgesetz (AMG) geregelt. Nach pharmakologischen und toxikologischen Tests der Substanzen in Tierversuchen wird ihre Wirksamkeit und Verträglichkeit in klinischen Studien an gesunden Probanden und Patienten geprüft. Die Anzahl an Studienteilnehmern ist bei Arzneimitteln so bemessen, dass akute Risiken mit einer Wahrscheinlichkeit von 0,1 % erfasst werden; seltenere Risiken werden in den Studien vor Zulassung nicht erfasst. Bei Medizingeräten erfolgt eine Konformitätsprüfung in Bezug auf die Einhaltung von Leistungsgrenzen und Sicherheitsstandards nach den Bestimmungen der Medizingeräteverordnung. Hinreichende Langzeitdaten fehlen bei beiden Verfahren zu Beginn der Vermarktung, sodass parallel zur Anwendung Anwendungsrisiken erfasst und bewertet werden müssen. / The safety concepts applied in the development of new drugs are based on individual tests of each new chemical entity. The applicable law is codified in the German Medicines Act (AMG). Alongside animal experimentation (pharmacology and toxicology), efficacy and tolerability are evaluated in clinical trials conducted with healthy human volunteers and patients. The population exposure is calculated in such a way that acute effects with a probability of 0.1 % are displayed; rarer risks are usually not detected in clinical trials prior to the approval of new drugs. Medical devices are tested regarding their conformity with predefined safety standards and power intensities. Adequate long term data are still missing in both cases at the time of market launch. Consequently, it is necessary to report and assess risks during actual use.

Made available in DSpace on 2014-10-09T12:28:51Z (GMT). No. of bitstreams: 0 / Made available in DSpace on 2014-10-09T13:57:06Z (GMT). No. of bitstreams: 0 / Dissertacao (Mestrado Profissionalizante em Lasers em Odontologia) / IPEN/D-MPLO / Instituto de Pesquisas Energeticas e Nucleares - IPEN-CNEN/SP; Faculdade de Odontologia, Universidade de Sao Paulo, Sao Paulo

Made available in DSpace on 2014-10-09T12:28:51Z (GMT). No. of bitstreams: 0 / Made available in DSpace on 2014-10-09T13:57:06Z (GMT). No. of bitstreams: 0 / Dissertacao (Mestrado Profissionalizante em Lasers em Odontologia) / IPEN/D-MPLO / Instituto de Pesquisas Energeticas e Nucleares - IPEN-CNEN/SP; Faculdade de Odontologia, Universidade de Sao Paulo, Sao Paulo

Die Sicherheitsphilosophie bei der Entwicklung neuer Arzneimittel besteht in einer individuellen Prüfung der sicherheitsrelevanten Eigenschaften neuer Substanzen und ist durch das Arzneimittelgesetz (AMG) geregelt. Nach pharmakologischen und toxikologischen Tests der Substanzen in Tierversuchen wird ihre Wirksamkeit und Verträglichkeit in klinischen Studien an gesunden Probanden und Patienten geprüft. Die Anzahl an Studienteilnehmern ist bei Arzneimitteln so bemessen, dass akute Risiken mit einer Wahrscheinlichkeit von 0,1 % erfasst werden; seltenere Risiken werden in den Studien vor Zulassung nicht erfasst. Bei Medizingeräten erfolgt eine Konformitätsprüfung in Bezug auf die Einhaltung von Leistungsgrenzen und Sicherheitsstandards nach den Bestimmungen der Medizingeräteverordnung. Hinreichende Langzeitdaten fehlen bei beiden Verfahren zu Beginn der Vermarktung, sodass parallel zur Anwendung Anwendungsrisiken erfasst und bewertet werden müssen. / The safety concepts applied in the development of new drugs are based on individual tests of each new chemical entity. The applicable law is codified in the German Medicines Act (AMG). Alongside animal experimentation (pharmacology and toxicology), efficacy and tolerability are evaluated in clinical trials conducted with healthy human volunteers and patients. The population exposure is calculated in such a way that acute effects with a probability of 0.1 % are displayed; rarer risks are usually not detected in clinical trials prior to the approval of new drugs. Medical devices are tested regarding their conformity with predefined safety standards and power intensities. Adequate long term data are still missing in both cases at the time of market launch. Consequently, it is necessary to report and assess risks during actual use.

Thesis (LLM.) -- University of Limpopo, 2017. / In South Africa, during the then apartheid era, the mining sector had records of extremely high fatalities, injuries and occupational diseases that led to massive death of miners predominantly the Blacks. In the post-apartheid era, numerous laws have been enacted to address the problem. One of the laws that was introduced is the Mine Health and Safety Act 29 of 1996 which provides for radical enforcement of health and safety standards using various mechanisms, such as monitoring systems and inspections, investigations, and employers' and employees' duties to identify hazards and eliminate, control and minimise the risk to health and safety of mine workers. This study examines the extent, efficient and efficacy of the implementation and enforcements of these laws and points out the challenges being encountered and prospects made thus far. The study used Australia and Chile for comparative study and showcased how the government and the laws they have passed are being effectively used to contain and curtail health hazards, accidents and fatalities in the mining environment.

The impact of domestic policy regulations and standards on trade has been at the forefront of global policy during the past decade. Every country develops their own policies and standards that differ from country to country. These differences create problems for manufacturing industries, especially in major exporting countries. This study overviews the policy context driving standards in the manufacturing industries. The study consists of three different articles that attempt to examine the role of technical regulations and standards and their relationship with trade using different econometric models In the first article, the standard factor endowment approach is employed to explain the effects of environmental regulatory policy on net exports in different manufacturing industries. The study hypothesizes that a countrys comparative advantage depends on its factor abundance. The regulatory policy increases production costs and, thus, reduces the output level of an industry. The results indicate that each industry is unique in the factors determining net exports and in many instances environmental regulations are important. In the second article, we investigate the impact of competition policy on a countrys production and export competitiveness. Since the impact of competition regulation depends upon the particular circumstances of the industry to which the policy is applied, we examine how competition policy impacts production and exports of a specific sector, in particular the agri-food processing sector. The results suggest that competition policy enhances competition by reducing entry barriers, and causes firms to produce more output with lower prices. Exports for both total and food manufacturing in the post-competition policy period are higher than exports in the pre-competition period. In the third article, we estimate regressions based on an extended gravity model to determine the possible influence of food safety standards on export flows of six Asia-Pacific countries to ten importing countries. We examine the relationship between bilateral exports and importers imposition of food safety standards. The results show that the value of exports in food and food products is negatively affected by food safety standards: the greater the aflatoxin standards, the lower its restrictiveness, and higher the bilateral export flows.

Thesis (MPH.) -- University of Limpopo, 2012

The aim of the present thesis is twofold: first, to analyse some practical ethical problems that stem from the workplace and the working environment and to offer guidelines concerning how such problems can be solved; second, to illuminate how the specific nature of work and the working environment is intimately connected to the relation between the employee and the employing entity, as set forth in an employment contract, and how the form and content of such contracts are, among other things, determined by culturally and socially established ideas. The normative question to be addressed is thus: which of these ideas should be maintained? This can be seen as a second-order, or more fundamental, ethical question whose answer depends on determining which normative principles are right. An additional aim of this thesis is thus to illuminate that the contract relation has relevance to practical ethical problems in the workplace context in this second-order mode. The thesis consists of an Introduction and five papers. In Paper I (written together with Sven Ove Hansson) we argue that employees have a prima facie right to privacy, but that this right can be overridden by competing moral principles that follow, explicitly or implicitly, from the contract of employment. A set of ethical criteria is developed and summarized in the form of a guideline for determining the moral status of infringements into workplace privacy. In Paper II these criteria are applied to three broad classes of privacy-intrusive workplace practices: (1) monitoring and surveillance, (2) genetic testing, and (3) drug testing. In relation to some scenarios on these themes, it is shown that it is possible to handle such practical ethical problems systematically by way of the proposed guideline. Paper III deals with the fact that employees are protected by health and safety standards that are less protective than those that apply to the general public. Emphasis is put on the distinction between exposure and risk, and this distinction is claimed to be a key determinant for the relevance of arguments put forward in support of such double standards. In Paper IV the nature of the contract of employment is explored from an ethical point of view. An argument is developed against the claim that (a) the individual’s freedom of decision and (b) the practice of institutional arrangements are sufficient to justify a contract of employment. Paper V questions the standpoint that the voluntariness of the contracting parties in an employment relationship has substantial value. One overarching issue concerns the meaning of voluntariness in the employment context, another, its normative importance. It is argued that it is indeterminate exactly where the line should be drawn between voluntary and non–voluntary agreements in this context. Concerning the latter issue, it is claimed that even if we were able to draw such a line, this fact does not tell us anything about the normative importance of the voluntariness condition, nor how much normative weight we should assign to the fulfilment of its conditions in the workplace context. / QC 20100915

The “Development of an existing engraving machine by designing a protection cabin for laser marking”project consists of the achievement of a protection cabin for a marking laser by applying the theory and the experience acquired during the courses in Mechanical Engineering program. Degree project is made with the Maskinteknik i Oskharsham AB by the Mechanical Engineering student, Ahmet Azman and Sabra Meradi. This protection cabin is design for the Deckel GK 21 engraving machine that company already bought it several years ago. The safety requirements for laser protection cabin shown in IEC and ISO standard will be observed. The design process explained in the GETTING DESIGN RIGHT: A Systems Approach book will be followed to achieve this project. Six steps of this method are followed: Define the problem, Measure the needs and set targets, Explore the design space, Optimize design choices, Develop the architecture, Validate the project.

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