Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall appraisal of benefits and risks of medicines. Benefit-Risk Appraisal of Medicines establishes the background and criteria required to assess benefit and risk in general and reviews the current practices by regulatory authorities and the pharmaceutical industry, including those models currently available. It outlines the development and evaluation of the authors’ new model and analyses the implications of its implementation. Describes an innovative, systematic model which leads to transparent and responsible benefit-risk decision making Contributes important ideas to the debate on benefit-risk appraisal Provides a future framework for benefit-risk appraisal of medicines Benefit-Risk Appraisal of Medicines covers the entire process from the discovery of new medicines to their marketing and is ideal for all those who work in the pharmaceutical industry and regulatory authorities,, as well as post-graduate students of pharmaceutical medicine and clinical pharmacology.
Jonas hat es nicht leicht: Er muss sich um seine kranke Mutter kümmern und nebenbei sein Jurastudium durch harte Arbeit auf Stockholms Baustellen verdienen. Dabei leidet er immer wieder unter heftigen Migräneanfällen. Während einer solchen Attacke hat er eines Tages einen schrecklichen Unfall, den er wie durch ein Wunder überlebt. Bei der schnell eingeleiteten Operation entfernen die Ärzte eine merkwürdige Kapsel in Jonas’ Kopf – und von dem Moment an ist seine Welt nicht mehr die, die sie war. Es gehen seltsame Dinge vor sich, und während Jonas verzweifelt nach Antworten sucht, wird er plötzlich selbst zum Gejagten ...
Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall appraisal of benefits and risks of medicines. Benefit-Risk Appraisal of Medicines establishes the background and criteria required to assess benefit and risk in general and reviews the current practices by regulatory authorities and the pharmaceutical industry, including those models currently available. It outlines the development and evaluation of the authors’ new model and analyses the implications of its implementation. Describes an innovative, systematic model which leads to transparent and responsible benefit-risk decision making Contributes important ideas to the debate on benefit-risk appraisal Provides a future framework for benefit-risk appraisal of medicines Benefit-Risk Appraisal of Medicines covers the entire process from the discovery of new medicines to their marketing and is ideal for all those who work in the pharmaceutical industry and regulatory authorities,, as well as post-graduate students of pharmaceutical medicine and clinical pharmacology.
In 2015 vond aan het Sint-Janscentrum een wetenschappelijk colloquium plaats met internationale sprekers, naar aanleiding van de verjaardag van de val van de Berlijnse Muur. De teksten van de lezingen, die gehouden werden tijdens dit colloquium, zijn nu verzameld in de bundel Secularisation & Europe , een uitgave van uitgeverij Betsaida in samenwerking met de wetenschappelijke uitgeverij van de Pauselijke Universiteit Johannes Paulus II in Krakau.
The foreign trade is the engine of the global economics. In these turbulent days, when governments and international organizations tend to protect their markets spheres of interest, the application of regulatory measures gains in importance. The Czech Yearbook of International Law - Regulatory Measures and Foreign Trade - 2013 pinpoints these trends and its various aspects on different levels in comparative analysis. The Yearbook provides insight into problematic of regulatory measures in investment law on global level same as from the EU prospective. Similarly, authors also analyze various aspects of the regulatory measures applied in the areas of financial markets and money laundering, market abuse, Common European Sales Law and Consumer Protection. Local practitioners from the region also share their views on the measures in foreign trade on the domestic level and the problems interconnected with such regulation in the region. The new volume of the Czech Yearbook of International Law - Regulatory Measures and Foreign Trade - 2013 brings useful resource for everyone who is dealing with international trade, be it an academic, practitioner, law or international relations student who seeks global compendium on the issue including an overlap to economic and politic aspects of the problematic.
Englisch sprechen lernen in Alltagssituationen Gewinnen Sie Selbstvertrauen im täglichen Umgang mit der englischen Sprache. Übersetzen Sie authentische, lebendige Sätze aus dem Alltag, wie z. B. Freunde treffen, beim Check-in am Flughafen, im Restaurant, beim Arzt und viele viele mehr … Zusätzliche Tipps und Wortschatz helfen beim Übersetzen. Let’s practise! In jedem Kapitel gibt es Anregungen,wie man das Erlernte üben kann.
The Czech Yearbooks Project, for the moment made up of the Czech Yearbook of International Law® and the Czech (& Central European) Yearbook of Arbitration®, began with the idea to create an open platform for presenting the development of both legal theory and legal practice in Central and Eastern Europe and the approximation thereof to readers worldwide. This platform should serve as an open forum for interested scholars, writers, and prospective students, as well as practitioners, for the exchange of different approaches to problems being analyzed by authors from different jurisdictions, and therefore providing interesting insight into issues being dealt with differently in many different countries.
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