A History of Therapeutic Goods Regulation in Australia PDF Download
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Author: John McEwan
Publisher:
ISBN: 9780980422900
Category : Drugs
Languages : en
Pages : 170
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Book Description
Author: John McEwan
Publisher:
ISBN: 9780980422900
Category : Drugs
Languages : en
Pages : 170
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Book Description
Author: Desmond Manderson
Publisher: Oxford University Press, USA
ISBN:
Category : History
Languages : en
Pages : 300
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Book Description
In this compelling legal and social history of the origins and development of drug laws in Australia, Desmond Manderson traces, in a lively and irreverent style, the gradual politicization of the drug law debate. He argues that the selective enactment of drug laws has been driven by fear, racism, powerful international pressures, and the vested interests of the medical profession, bureaucrats, and politicians, rather than by genuine concerns about the welfare of users. Behind the controversy that surrounds illegal drug use lie previously unexamined assumptions about how and why certain substances, such as opium, heroin, and cannibis, have been prohibited, while others, namely tobacco and alcohol, have not. Manderson boldly challenges these assumptions, while evaluating the power and efficacy of law as a means of achieving social change.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169
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Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
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Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Author: Adrian Kilcoyne
Publisher: OUP Oxford
ISBN: 0191510394
Category : Medical
Languages : en
Pages : 473
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Book Description
The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Author: Penny Gleeson
Publisher: Taylor & Francis
ISBN: 1040297072
Category : Law
Languages : en
Pages : 210
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Book Description
This book develops a theoretical framework for examining and assessing the regulatory arrangements for medical products. Since the first half of the 20th century, the regulation of pharmaceuticals, medical devices and, more recently, biologicals have been controlled in many jurisdictions by specific regulatory regimes and agencies. Their regulatory mandates are similar – to ensure the quality, safety and efficacy of medical products. This book provides a timely and relevant assessment of the complexities of medical regulatory regimes, by drawing on a particular theory of political legitimacy. In this respect, the book adopts a ‘dialogic’ approach – according to which a shared set of normative beliefs and values are formulated – as a theoretical ‘tool’ to identify deficiencies in the regulatory arrangements for medical products. Drawing on several Australian cases studies, characterised by divergent normative perspectives, the book develops its dialogic approach in order to challenge the usual legitimation of regulatory regimes from the perspective of science alone. Specifically, it maintains that such regimes need to embrace a normative pluralism that admits a diversity of types and sources of knowledge. This evaluation of the increasingly influential domain of medical regulation will appeal to a range of scholars and practitioners working in law, public health, politics and science and technology studies.
Author: The Law The Law Library
Publisher: Createspace Independent Publishing Platform
ISBN: 9781720604914
Category :
Languages : en
Pages : 92
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Book Description
Narcotic Drugs Act 1967 (Australia) (2018 Edition) The Law Library presents the complete text of the Narcotic Drugs Act 1967 (Australia) (2018 Edition). Updated as of May 15, 2018 This book contains: - The complete text of the Narcotic Drugs Act 1967 (Australia) (2018 Edition) - A table of contents with the page number of each section
Author: National Health and Medical Research Council (Australia)
Publisher:
ISBN: 9780648464426
Category : Human rights
Languages : en
Pages : 0
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Book Description
"The purpose of the National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community. The National Statement is therefore designed to clarify the responsibilities of: institutions and researchers for the ethical design, conduct and dissemination of results of human research ; and review bodies in the ethics review of research. The National Statement will help them to meet their responsibilities: to identify issues of ethics that arise in the design, review and conduct of human research, to deliberate about those ethical issues, and to justify decisions about them"--Page 6.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241515430
Category : Business & Economics
Languages : en
Pages : 228
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Book Description
This report is structured in five parts: national framework for traditional and complementary medicine (T&CM); product regulation; practices and practitioners; the challenges faced by countries; and finally the country profiles. Apart from the section on practices and practitioners the report is consistent with the format of the report of the first global survey in order to provide a useful comparison. The section on practices and practitioners which covers providers education and health insurance is a new section incorporated to reflect the emerging trends in T&CM and to gather new information regarding these topics at a national level. All new information received has been incorporated into individual country profiles and data graphs. The report captures the three phases of progress made by Member States; that is before and after the first WHO Traditional Medicine Strategy (1999?2005) from the first global survey to the second global survey (2005?2012) and from the second survey to the most recent timeline (2012?2018).
Author: Peter Drahos
Publisher: ANU Press
ISBN: 1760461024
Category : Law
Languages : en
Pages : 820
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Book Description
This volume introduces readers to regulatory theory. Aimed at practitioners, postgraduate students and those interested in regulation as a cross-cutting theme in the social sciences, Regulatory Theory includes chapters on the social-psychological foundations of regulation as well as theories of regulation such as responsive regulation, smart regulation and nodal governance. It explores the key themes of compliance, legal pluralism, meta-regulation, the rule of law, risk, accountability, globalisation and regulatory capitalism. The environment, crime, health, human rights, investment, migration and tax are among the fields of regulation considered in this ground-breaking book. Each chapter introduces the reader to key concepts and ideas and contains suggestions for further reading. The contributors, who either are or have been connected to the Regulatory Institutions Network (RegNet) at The Australian National University, include John Braithwaite, Valerie Braithwaite, Peter Grabosky, Neil Gunningham, Fiona Haines, Terry Halliday, David Levi-Faur, Christine Parker, Colin Scott and Clifford Shearing.
