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The Law And Regulation Of Medicines

The Law and Regulation of Medicines PDF
Author: Peter Feldschreiber
Publisher: Oxford University Press, USA
ISBN: 9780199534678
Size: 78.96 MB
Format: PDF, Kindle
Category : Law
Languages : en
Pages : 473
View: 3795

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This is a comprehensive textbook on the science, regulatory policy and law surrounding the discovery, development and marketing of new medicines. It is designed as a reference work for legal, medical and pharmaceutical professionals working in the fields of medicine regulation, medical law and product liability. The authors are a group of specialists in pharmaceutical medicine, pharmacology and therapeutics and lawyers specialising in product liability law andintellectual property. Serving as a practical introduction for practitioners wishing to undertake work in this highly complex area of law, this book is specifically designed to facilitate deeper mutual understanding of the technical issues for the lawyer and the legal issues for those involved withregulatory policy and decision making.

Law And The Regulation Of Medicines

Law and the Regulation of Medicines PDF
Author: Emily Jackson
Publisher: Bloomsbury Publishing
ISBN: 1847319092
Size: 64.21 MB
Format: PDF, Docs
Category : Law
Languages : en
Pages : 308
View: 2724

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The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.

Law And The Regulation Of Medicines

Law and the Regulation of Medicines PDF
Author: Emily Jackson
Publisher: Bloomsbury Publishing
ISBN: 1847319084
Size: 38.13 MB
Format: PDF, Mobi
Category : Law
Languages : en
Pages : 308
View: 6807

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The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.

The Law And Ethics Of The Pharmaceutical Industry

The Law and Ethics of the Pharmaceutical Industry PDF
Author: M.N.G. Dukes
Publisher: Elsevier
ISBN: 9780080459363
Size: 18.96 MB
Format: PDF, ePub, Docs
Category : Medical
Languages : en
Pages : 422
View: 5744

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As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation. Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change. *Provides a balanced picture of the current role of the pharmaceutical industry in society *Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases *This is the only book addressing the legal implications of big pharma activities and ethical standards

Routledge Handbook Of Complementary And Alternative Medicine

Routledge Handbook of Complementary and Alternative Medicine PDF
Author: Nicola K. Gale
Publisher: Routledge
ISBN: 1136685480
Size: 46.98 MB
Format: PDF, ePub, Mobi
Category : Social Science
Languages : en
Pages : 410
View: 6142

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The provision and use of traditional, complementary and alternative medicine (CAM) has been growing globally over the last 40 years. As CAM develops alongside - and sometimes integrates with - conventional medicine, this handbook provides the first major overview of its regulation and professionalization from social science and legal perspectives. The Routledge Handbook of Complementary and Alternative Medicine draws on historical and international comparative research to provide a rigorous and thematic examination of the field. It argues that many popular and policy debates are stuck in a polarized and largely asocial discourse, and that interdisciplinary social science perspectives, theorising diversity in the field, provide a much more robust evidence base for policy and practice in the field. Divided into four sections, the handbook covers: analytical frameworks power, professions and health spaces risk and regulation perspectives for the future. This important volume will interest social science and legal scholars researching complementary and alternative medicine, professional identify and health care regulation, as well as historians and health policymakers and regulators.

Medicine Patients And The Law

Medicine  patients and the law PDF
Author: Margaret Brazier
Publisher: Manchester University Press
ISBN: 1526100517
Size: 39.89 MB
Format: PDF, Mobi
Category : Law
Languages : en
Pages : 856
View: 7580

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Embryo research, cloning, assisted conception, neonatal care, saviour siblings, organ transplants, drug trials - modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up. In this highly acclaimed and very accessible book, now in its sixth edition, Margaret Brazier and Emma Cave provide an incisive survey of the legal situation in areas as diverse as fertility treatment, patient consent, assisted dying, malpractice and medical privacy. The book has been fully revised and updated to cover the latest cases, from assisted dying to informed consent; legislative reform of the NHS, professional regulation and redress; European regulations on data protection and clinical trials; and legislation and policy reforms on organ donation, assisted conception and mental capacity. Essential reading for healthcare professionals, lecturers, medical and law students, this book is of relevance to all whose perusal of the daily news causes wonder, hope and consternation at the advances and limitations of medicine, patients and the law.

Private Law In The External Relations Of The Eu

Private Law in the External Relations of the EU PDF
Author: Marise Cremona
Publisher: Oxford University Press
ISBN: 0191062014
Size: 23.27 MB
Format: PDF
Category : Law
Languages : en
Pages : 350
View: 3804

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Private Law in the External Relations of the EU is an innovative study of the interactions between EU external relations law and private law, two unrelated fields of law, inverted if private law is understood as regulatory private law - the space where regulatory law intersects with private economic activity. Here the link between the Internal Market and the global market - and thereby international law - is much more prominent. In this book, key questions about the relationship between EU external relations law and private law are answered, including: in what ways might European private law act as a tool to achieve EU external policy objectives, particularly in regulatory fields? How might the quickly developing EU external competence over the procedural dimensions of private law, including private international law, impact on substantive law, both externally and internally? And how is the legal position of private parties affected by EU external relations? In asking these questions, this edited collection opens up a field of enquiry into the so far underexplored relationship between these two fields of law. In doing so, it addresses three different aspects of the relationship: (i) the evolution of the EU competence, (ii) the ways in which EU private law extends its reach beyond the boundaries of the internal market, and (iii) the ways in which the EU contributes to the formation of private regulation at the international level.