Law And The Regulation Of Medicines

Law and the Regulation of Medicines PDF
Author: Emily Jackson
Publisher: Bloomsbury Publishing
ISBN: 1847319092
Size: 43.38 MB
Format: PDF, Mobi
Category : Law
Languages : en
Pages : 308
View: 6548

Get Book

Law And The Regulation Of Medicines

by Emily Jackson, Law And The Regulation Of Medicines Books available in PDF, EPUB, Mobi Format. Download Law And The Regulation Of Medicines books, 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.


In Vitro Diagnostic Medical Devices Law And Practice In Five Eu Member States

In vitro Diagnostic Medical Devices  Law and Practice in Five EU Member States PDF
Author: Bernhard M. Maassen
Publisher: Springer Science & Business Media
ISBN: 9780792329961
Size: 71.75 MB
Format: PDF, Docs
Category : Law
Languages : en
Pages : 118
View: 5107

Get Book

In Vitro Diagnostic Medical Devices Law And Practice In Five Eu Member States

by Bernhard M. Maassen, In Vitro Diagnostic Medical Devices Law And Practice In Five Eu Member States Books available in PDF, EPUB, Mobi Format. Download In Vitro Diagnostic Medical Devices Law And Practice In Five Eu Member States books, Preface by T. Morrison, Director-General of the European Diagnostic Manufacturers Association. Contributors: W. Kewenig; G. Forlani, J. Marriage, G. Ulloa This book is based upon a report prepared at the request of the European Commission. Its purpose is to set out the existing laws regulating the development, production, distribution and use of in vitro diagnostic medical devices (IVDMD) in the U.K., Germany, France, Italy and Spain. Each national section has the same structure and covers the same ground in order to enable comparisons. IVDM Devices includes not only reagents, but also technical instruments, or combination of both, for human use. The book is directed towards industry and the regulation is covered with a high degree of specificity. This reference book, completely written in English, is the only comprehensive exposition of the laws of the five countries regarding IVDM Devices available. It is also the most convenient means of comparing those laws. As such, it will be a useful guide to all IVDM Devices manufacturers interested in the European market.


Medicines Medical Devices And The Law

Medicines  Medical Devices and the Law PDF
Author: John O'Grady
Publisher: Cambridge University Press
ISBN: 0521292514
Size: 61.27 MB
Format: PDF
Category : Law
Languages : en
Pages : 428
View: 494

Get Book

Medicines Medical Devices And The Law

by John O'Grady, Medicines Medical Devices And The Law Books available in PDF, EPUB, Mobi Format. Download Medicines Medical Devices And The Law books, The need for specialist knowledge of the laws governing the regulation of medicines has become apparent. This is the case among not only lawyers but also hospitals, researchers, prescribers and many others involved in the provision of healthcare. Such a need has been precipitated by a number of factors, including the changing structure of healthcare in the UK and Europe and the various changes in regulation that have arisen both from challenges in the courts and from the intervention of public bodies. However, the information available to those involved in the complex interrelations between medicines, medical devices and the law have remained scarce. This book aims to address this situation by bringing together the knowledge of the laws governing the regulation of medicines ranging across the field from the ethics of the use of medicines in treatment and research, through to drug-induced injury, civil liability and no-fault compensation schemes.


Regulation Of And By Pharmacists In The Netherlands And Belgium

Regulation of and by Pharmacists in the Netherlands and Belgium PDF
Author: Niels Philipsen
Publisher: Intersentia nv
ISBN: 9050953514
Size: 58.82 MB
Format: PDF, ePub, Mobi
Category : Law
Languages : en
Pages : 195
View: 768

Get Book

Regulation Of And By Pharmacists In The Netherlands And Belgium

by Niels Philipsen, Regulation Of And By Pharmacists In The Netherlands And Belgium Books available in PDF, EPUB, Mobi Format. Download Regulation Of And By Pharmacists In The Netherlands And Belgium books, This book examines the regulation of pharmacists in the Netherlands and Belgium from the perspective of law and economics. It starts with an extensive and accessible overview of the economic literature with respect to the regulation (including self-regulation) of liberal professions. Subsequently, this book analyses the extent to which the current regulation of Dutch and Belgian pharmacists serves the public interest and the extent to which this regulation is a result of rent-seeking behaviour by private interest groups. The author concludes that some regulation, notably with respect to advertising, design of the pharmacy, establishment of pharmacies and drug prices, does not seem to serve the public interest. Moreover, he criticises the regulation of reimbursement for the pharmacist, which in both countries is still linked to the phar-macists monopoly in the distribution of drugs, despite new tasks of the pharmacist in the field of pharmaceutical care. In addition to a theoretical analysis, the author carries out an empirical research of rent-seeking behaviour in the pharmaceutical market. Although the book studies the situation in the Netherlands and in Belgium, its conclusions will certainly apply to other countries and other professions. The book will therefore be of interest to all economists, lawyers and practitioners interested in regulation of the liberal professions as well as practitioners and academics working in the field of health care.


The Politics Of Pharmaceutical Policy Reform

The Politics of Pharmaceutical Policy Reform PDF
Author: Elize Massard da Fonseca
Publisher: Springer
ISBN: 3319125656
Size: 58.19 MB
Format: PDF, Kindle
Category : Political Science
Languages : en
Pages : 117
View: 4878

Get Book

The Politics Of Pharmaceutical Policy Reform

by Elize Massard da Fonseca, The Politics Of Pharmaceutical Policy Reform Books available in PDF, EPUB, Mobi Format. Download The Politics Of Pharmaceutical Policy Reform books, Brazil is renowned worldwide for its remarkable reforms in pharmaceutical regulation, which have enhanced access to essential medicines while lowering drug costs. This book innovates by analysing the generic drug reform in Brazil, demonstrating that pharmaceutical regulation is only partially influenced by non-state actors. Little is known about the institutional antecedents and policy process that channeled this regulatory reform. This is particularly intriguing because a regulatory shift in the pharmaceutical sector requires the participation of a number of stakeholders and interest groups in the policy process. Fonseca examines the generic drug reform’s causes and consequences. No study has approached the generic drug regulation in Brazil from this perspective. The Politics of Pharmaceutical Policy Reform: A Study of Generic Drug Regulation in Brazil, explores the following: · The politics of pharmaceutical regulation in Brazil over the last 25 years. · The political negotiations to approve the Generic Drug Act, which involved a hard-to-reach agreement between the pharmaceutical industry (national and multinational), the Ministry of Health, and Congress · The controversial decisions to regulate packaging and pharmaceutical equivalence. · The surprising success of Brazilian pharmaceutical firms, which became market champions in a sector largely dominated by multinational firms. · Comparative lessons from the Brazilian case for the political construction of regulatory standards to regulate generic drugs and its effects on global health. This book will interest political scientists and health policy scholars concerned with the political conflicts in the pharmaceutical sector. It argues against well-established approaches to regulatory capture such as control of the regulatory process by interest groups and policy diffusion. It can be used as evidence for graduate courses in public policy, health policy and political science. Because Brazil is one of the largest markets for pharmaceuticals in the world, business leaders and consultancy firms would also be interested.


Pharmaceutical Practice International Edition E Book

Pharmaceutical Practice  International Edition E Book PDF
Author: Arthur J. Winfield
Publisher: Elsevier Health Sciences
ISBN: 0702041874
Size: 43.99 MB
Format: PDF, Kindle
Category : Medical
Languages : en
Pages : 644
View: 929

Get Book

Pharmaceutical Practice International Edition E Book

by Arthur J. Winfield, Pharmaceutical Practice International Edition E Book Books available in PDF, EPUB, Mobi Format. Download Pharmaceutical Practice International Edition E Book books, This comprehensive book covers a wide range of subjects relevant to pharmacy practice, including communication skills, managing a business, quality assurance, dispensing, calculations, packaging, storage and labeling of medicines, sterilization, prescriptions, hospital-based services, techniques and treatments, adverse drug reactions, pharmacoeconomics, and medicines management. Features useful appendices on medical abbreviations, pharmaceutical Latin terms, weights and measures, and presentation skills. This is a core text for pharmacy practice and dispensing modules of the pharmacy curriculum Covers key exam material for essential review and test preparation Features a user-friendly design with clear headings, chapter summaries, helpful boxes, and key points Text restructured with 14 new or radically revised chapters. All text revised in light of current pharmaceutical practice. New design using two colours.


Pharmacology For Health Professionals Ebook

Pharmacology for Health Professionals ebook PDF
Author: Bronwen Bryant
Publisher: Elsevier Health Sciences
ISBN: 0729581713
Size: 39.58 MB
Format: PDF, ePub, Mobi
Category : Medical
Languages : en
Pages : 1166
View: 7769

Get Book

Pharmacology For Health Professionals Ebook

by Bronwen Bryant, Pharmacology For Health Professionals Ebook Books available in PDF, EPUB, Mobi Format. Download Pharmacology For Health Professionals Ebook books, Perfect for: Undergraduate Health science, Paramedic science, Nursing, Midwifery, Podiatry and Optometry students. Pharmacology for Health Professionals 4th Edition provides a comprehensive introduction to fundamental pharmacology principles and concepts. The fourth edition has been fully updated and revised to reflect the most up-to-date information on the clinical use of drugs, Australian and New Zealand scheduling, drug legislation and ethics. • Anatomy and physiology integrated throughout • Discipline-specific information integrated throughout and additional resources provided via Evolve • Key drug information at your fingertips: Drug Monographs, Drug Interactions Tables, Clinical Interest Boxes and key terms and abbreviations • End-of-chapter review exercises to test your understanding. • Evolve resources for both lecturer and student. • New and updated Drug Monographs describing important aspects of drugs and drug groups • Updated tables outlining detailed drug interactions occurring with major drug groups • Recent changes in the pharmacological management of major conditions • New Clinical Interest Boxes, including current New Zealand specific and pharmacological treatment of common diseases and conditions • Referencing most up-to-date reviews of drugs and major disease management • Guidelines for clinical choice and use of drugs • Enhanced information on the use of complementary and alternative medicine (CAM) modalities, with a focus on interactions between drugs and CAM therapies • Improved internal design for ease of navigation.


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: 14.99 MB
Format: PDF
Category : Medical
Languages : en
Pages : 422
View: 4177

Get Book

The Law And Ethics Of The Pharmaceutical Industry

by M.N.G. Dukes, The Law And Ethics Of The Pharmaceutical Industry Books available in PDF, EPUB, Mobi Format. Download The Law And Ethics Of The Pharmaceutical Industry books, 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


Drugs And Drug Policy

Drugs and Drug Policy PDF
Author: Clayton J. Mosher
Publisher: SAGE
ISBN: 0761930078
Size: 33.26 MB
Format: PDF, Kindle
Category : Social Science
Languages : en
Pages : 501
View: 5648

Get Book

Drugs And Drug Policy

by Clayton J. Mosher, Drugs And Drug Policy Books available in PDF, EPUB, Mobi Format. Download Drugs And Drug Policy books, "...the authors provide a detailed review of existing drug policy in the United States and an excellent and thorough review of the effects of both legal and illegal substances. One of the book's outstanding features is its comprehensive coverage of policy regarding legal and non legal drugs...this book is also extremely thought provoking and challenges readers to consider the foundation of their own perspectives on drugs and drug policies." —PSYCCRITIQUES Drugs and Drug Policy: The Control of Consciousness Alteration provides a cross-national perspective on the regulation of drug use by examining and critiquing drug policies in the United States and abroad in terms of their scope, goals, and effectiveness. In this engaging text, authors Clayton J. Mosher and Scott Akins discuss the physiological, psychological, and behavioral effects of legal and illicit drugs; the patterns and correlates of use; and theories of the “causes” of drug use.