Pharmaceutical Regulatory Environment
Download Pharmaceutical Regulatory Environment full books in PDF, epub, and Kindle. Read online free Pharmaceutical Regulatory Environment ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Pharmaceutical Regulatory Environment
Author | : Reem K. Al-Essa,Mohammed Al-Rubaie,Stuart Walker,Sam Salek |
Publsiher | : Springer |
Total Pages | : 236 |
Release | : 2015-05-06 |
Genre | : Medical |
ISBN | : 9783319175904 |
Download Pharmaceutical Regulatory Environment Book in PDF, Epub and Kindle
This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.
Regulating Medicines in a Globalized World
Author | : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines |
Publsiher | : National Academies Press |
Total Pages | : 169 |
Release | : 2020-04-25 |
Genre | : Medical |
ISBN | : 9780309498630 |
Download Regulating Medicines in a Globalized World Book in PDF, Epub and Kindle
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.
The Changing Economics of Medical Technology
Author | : Institute of Medicine,Committee on Technological Innovation in Medicine |
Publsiher | : National Academies Press |
Total Pages | : 225 |
Release | : 1991-02-01 |
Genre | : Medical |
ISBN | : 9780309044912 |
Download The Changing Economics of Medical Technology Book in PDF, Epub and Kindle
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Rare Diseases and Orphan Products
Author | : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development |
Publsiher | : National Academies Press |
Total Pages | : 442 |
Release | : 2011-04-03 |
Genre | : Medical |
ISBN | : 9780309158060 |
Download Rare Diseases and Orphan Products Book in PDF, Epub and Kindle
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
International Drug Regulatory Mechanisms
Author | : Albert I. Wertheimer |
Publsiher | : CRC Press |
Total Pages | : 382 |
Release | : 2022-02-15 |
Genre | : Medical |
ISBN | : 9781000112030 |
Download International Drug Regulatory Mechanisms Book in PDF, Epub and Kindle
Learn how international governments have committed themselves to improving access to quality health care! International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country’s experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization. In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government’s measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as: Iceland Canada Israel Malaysia Argentina Taiwan Mexico Italy International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines how—despite similar goals—price controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.
Basics of Regulatory Affairs for Pharma Professional
Author | : Dr. Jayesh Dhalani |
Publsiher | : Lulu.com |
Total Pages | : 127 |
Release | : 2024 |
Genre | : Electronic Book |
ISBN | : 9780359963232 |
Download Basics of Regulatory Affairs for Pharma Professional Book in PDF, Epub and Kindle
EBOOK Regulating Pharmaceuticals in Europe Striving for Efficiency Equity and Quality
Author | : Elias Mossialos,Monique Mrazek,Tom Walley |
Publsiher | : McGraw-Hill Education (UK) |
Total Pages | : 390 |
Release | : 2004-06-16 |
Genre | : Medical |
ISBN | : 9780335226559 |
Download EBOOK Regulating Pharmaceuticals in Europe Striving for Efficiency Equity and Quality Book in PDF, Epub and Kindle
"This thoughtful and comprehensive book represents the best work I have seen on the current situation concerning medication policies in the EU. It is not just that this is a very up-to-date compendium of facts and data across a wide variety of domains that impact on pharmaceutical regulation. The book is also strong on analysis of those facts as well." Jerry Avorn, Harvard Medical School. "This book offers a comprehensive examination of approaches to manage pharmaceutical expenditures in Europe. It is a must-read for those who seek to understand and navigate the changing regulatory environment for medicines in the European Union." Bernie O'Brien, McMaster University, Canada. The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of pharmaceutical regulation, this book examines approaches used to manage pharmaceutical expenditure across Europe and what impact these strategies have had on efficiency, quality, equity and cost of pharmaceutical care.Regulating Pharmaceuticals in Europe is an important book for students of health policy, regulation and management, and for health managers and policy makers. The editors: Elias Mossialos is Brian Abel-Smith Professor of Health Policy at the London School of Economics and Political Science and a Research Director of the European Observatory on Health Systems and Policies. Monique Mrazek is a Health Economist (Europe and Central Asia region) for the World Bank and formerly a Research Officer in Health Economics for the European Observatory on Health Systems and Policies. Tom Walley is Professor of Clinical Pharmacology at the University of Liverpool and Director of the UK National Health Technology Assessment Programme. Contributors: Julia Abelson, Christa Altenstetter, Vittorio Bertele’, Christine Bond, Marcel L. Bouvy, Colin Bradley, Steve Chapman, Anna Dixon, Michael Drummond, Pierre Durieux, Edzard Ernst, Armin Fidler, Eric Fortess, Richard Frank, Silvio Garattini, Leigh Hancher, Ebba Holme Hansen, Steve Hudson, Kees de Jonchere, Panos Kanavos, Sjoerd Kooiker, Jean-Marc Leder, Graham Lewis, Donald W. Light, Alistair McGuire, Elias Mossialos, Monique Mrazek, Maria Pia Orru', Govin Permanand, Guenka Petrova, Munir Pirmohamed, Dennis Ross-Degnan, Frans Rutten, Steven Soummerai, David Taylor, Sarah Thomson, Tom Walley.
Medical Regulatory Affairs
Author | : Jack Wong,Raymond K. Y. Tong |
Publsiher | : CRC Press |
Total Pages | : 620 |
Release | : 2022-01-27 |
Genre | : Medical |
ISBN | : 9781000440539 |
Download Medical Regulatory Affairs Book in PDF, Epub and Kindle
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.