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Pharmacovigilance in the European Union
This book is open access under a CC BY 4.0 license. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations, and thereby contribute to a better understanding of the factors that incentivize or impede the practical implementation of EU law at the national level.
Pharmacovigilance in the European Union
The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations, and thereby contribute to a better understanding of the factors that incentivize or impede the practical implementation of EU law at the national level. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.
Balancing between Trade and Risk
The trade aspects of risk and the risk aspects of trade deserve more systematic and genuine interdisciplinary attention if we are to really understand the global, international and supranational dimensions of risk regulation. This book brings together legal and social science research on risk regulation from across the world to explore risk regulation in a trade context. The interdisciplinary collaboration provided in this book is needed to address the trade versus risk balancing act both in empirical and theoretical terms. Although it is obvious that legal, social, cultural and political matters interfere with risk regulation, analyses in which these interferences are adequately considered ...
The Role of the Pharmacist in Patient Care
The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development in the pharmaceutical education and the evolving new roles of practicing pharmacists in patient care settings. This book focuses on...
The Law of Off-label Uses of Medicines
This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarif...
Risk and EU law
Risk and EU Law considers the multiple reasons for the increase in the types and diversity of risks, as well as the potential magnitude of their undesirable effects. The book identifies such reasons as; the openness of liberal societies; market competition; the constant endeavour to innovate; as well as globalization and the impact of new technologies. It also explores topics surrounding the social epistemology of risk observation and management, the role of science in political and judicial decision-making and transnational risk regulation and contractual governance.
European Objects
How interventions based on objects—including chemicals, financial products, and consumer goods—offer a path to rethink European integration. Interventions based on objects, Brice Laurent claims, have become a dominant path for European policy-making. In European Objects, Laurent analyzes the political consequences of these interventions and their democratization. He uses the term “European objects” to describe technical entities that are regulated—and thereby transformed—by European policies. To uncover the bureaucratic and regulatory intricacies of European governance, Laurent focuses on a series of these objects, including food products, chemicals, financial products, consumer ...
Europa von A bis Z
Dieses Taschenbuch bietet Europa zum Nachschlagen: In über 100 Sachbeiträgen erklären renommierte Europaexpertinnen und -experten wissenschaftlich fundiert und zugleich verständlich alle wichtigen Themen und Begriffe aus Politik, Wirtschaft und Geschichte der europäischen Einigung. Es erscheint in aktualisierter und erweiterter Fassung schon in der 15. Auflage und richtet sich an alle Europa-Interessierten, die sich gezielt und zuverlässig über den neusten Stand in europapolitischen Fragen informieren wollen.
