A History of Therapeutic Goods Regulation in Australia
Author: John McEwan
Publisher:
Published: 2007
Total Pages: 170
ISBN-13: 9780980422900
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Regulating Medicines in a Globalized World
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2020-04-25
Total Pages: 169
ISBN-13: 0309498635
DOWNLOAD EBOOKGlobalization 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.
The Regulation of E-cigarettes
Author: Lukasz Gruszczynski
Publisher: Edward Elgar Publishing
Published: 2019
Total Pages: 313
ISBN-13: 1788970462
DOWNLOAD EBOOKCombining the insights of leading legal scholars and public health experts, this unique book analyses the various legal problems that are emerging at different levels of governance (international, European and national) in the context of the regulation of e-cigarettes. The expert authors assess in depth the possible application of the precautionary and harm reduction principles in this area, examine the legal constraints imposed on states by international and European rules, as well as the regulatory approaches currently in place in selected national jurisdictions.
National Statement on Ethical Conduct in Human Research 2023
Author: National Health and Medical Research Council (Australia)
Publisher:
Published: 2023
Total Pages: 0
ISBN-13: 9780648464426
DOWNLOAD EBOOK"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.
Pharmaceutical Medicine
Author: Adrian Kilcoyne
Publisher: OUP Oxford
Published: 2013-05-23
Total Pages: 473
ISBN-13: 0191510394
DOWNLOAD EBOOKThe 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.
From Mr. Sin to Mr. Big
Author: Desmond Manderson
Publisher: Oxford University Press, USA
Published: 1993
Total Pages: 298
ISBN-13:
DOWNLOAD EBOOKIn 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.
Medical Device Regulations
Author: Michael Cheng
Publisher: World Health Organization
Published: 2003-09-16
Total Pages: 54
ISBN-13: 9241546182
DOWNLOAD EBOOKThe 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.
WHO Global Report on Traditional and Complementary Medicine 2019
Author: World Health Organization
Publisher: World Health Organization
Published: 2019-05-16
Total Pages: 228
ISBN-13: 9241515430
DOWNLOAD EBOOKThis 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).
A Critical Review of Australia’s Regulatory Oversight For New Generation Personalised Medical Devices
Author: Aman Grewal
Publisher: Ethics International Press
Published: 2024-09-16
Total Pages: 207
ISBN-13: 1804417297
DOWNLOAD EBOOKAustralia's medical device regulator Therapeutic Goods Administration (TGA) generally uses the term personalised medical device to describe medical devices made available to address specific individual requirements. 2019 Regulatory amendments including new definitions for personalised medical devices involved the subdivision of personalised medical devices into three categories of custom-made medical devices, patient-matched medical devices and adaptable medical devices, and the adaptation of the International Medical Device Regulatory Forum's (IMDRF’s) definitions for personalised medical devices. This book highlights inadequacies and oversights in the current regulatory regime, and explores possible solutions to address them. The study focuses on the regulatory control of personalised medical devices in Australia, but elements of the proposed regime are also compared with similar elements within the United States and South Korean medical device regulatory frameworks. The book also explores some technically complex medical and legal principles and issues that arise and interact with each other in the application of personalised medical devices. It concludes with specific observations and recommendations aimed at improving the current Australian regulatory framework for new-generation personalised medical devices. This study also examines the benefits and drawbacks of the IMDRF-led regulatory reforms in various international jurisdictions. The IMDRF is spearheading medical device international regulatory alignment; therefore, the scope and significance of the information discussed is important in international jurisdictions. This detailed study is a key reference work for academic researchers, medical device manufacturers and sponsors, and legal and regulatory experts.
Clinical Trials Handbook
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Published: 2009-06-17
Total Pages: 1247
ISBN-13: 0470466359
DOWNLOAD EBOOKBest practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
