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Author : Anonim
Publisher : Unknown
Page : 414 pages
File Size : 48,7 Mb
Release : 1980
Category : Drugs
ISBN : 385742205X
Author : International Federation of Pharmaceutical Manufacturers Association
Publisher : Unknown
Page : 324 pages
File Size : 43,6 Mb
Release : 1975
Category : Drug registration
ISBN : RUTGERS:390300029511110
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
Publisher : National Academies Press
Page : 169 pages
File Size : 44,6 Mb
Release : 2020-04-25
Category : Medical
ISBN : 9780309498630
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 : Anonim
Publisher : National Academies
Page : 208 pages
File Size : 54,6 Mb
Release : 1993
Category : Business & Economics
ISBN : UIUC:30112023352823
Author : J.E.S. Parker
Publisher : Springer
Page : 254 pages
File Size : 50,7 Mb
Release : 1984-06-18
Category : Business & Economics
ISBN : 9781349065998
Author : S.F. Spicker,Y.M. Healey Jr.,H. Tristram Engelhardt Jr.
Publisher : Springer Science & Business Media
Page : 307 pages
File Size : 54,5 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9789400984073
This volume is a contribution to the continuing interaction between law and medicine. Problems arising from this interaction have been addressed, in part, by previous volumes in this series. In fact, one such problem constitutes the central focus of Volume 5, Mental Illness: Law and Public Policy [1]. The present volume joins other volumes in this series in offering an exploration and critical analysis of concepts and values underlying health care. In this volume, however, we look as well at some of the general questions occasioned by the law's relation with medicine. We do so out of a conviction that medi cine and the law must be understood as the human creations they are, reflect ing important, wide-ranging, but often unaddressed aspects of the nature of the human condition. It is only by such philosophical analysis of the nature of the conceptual foundations of the health care professions and of the legal profession that we will be able to judge whether these professions do indeed serve our best interests. Such philosophical explorations are required for the public policy decisions that will be pressed upon us through the increasing complexity of health care and of the law's response to new and changing circumstances. As a consequence, this volume attends as much to issues in public policy as in the law. The law is, after all, the creature of human deci sions concerning prudent public policy and basic human rights and goods.
Author : Mindy J. Allport-Settle
Publisher : Pharmalogika
Page : 686 pages
File Size : 46,5 Mb
Release : 2009-12
Category : Law
ISBN : 0982147600
This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.
Author : M. D. B. Stephens,J. C. C. Talbot
Publisher : Springer
Page : 269 pages
File Size : 41,5 Mb
Release : 1985-06-18
Category : Medical
ISBN : 9781349072507
Author : Richard Blum,Andrew Herxheimer,Catherine Stenzl,Jasper Woodcock
Publisher : Routledge
Page : 230 pages
File Size : 52,8 Mb
Release : 2022-05-24
Category : Medical
ISBN : 9781000573152
Originally published in 1981, this comprehensive volume is intended for medical economists, clinical pharmacologists, physicians, pharmacists and consumers, as well as planner and administrators who must determine relevant policy and legislation in the area of the provision of medicines. The contributors believe that the system of drugs provision can benefit from being studied, by policy revisions and evaluation of the outcomes of policy operations.
Author : Leif Schaumann,Stanford Research Institute
Publisher : Unknown
Page : 28 pages
File Size : 53,7 Mb
Release : 1979
Category : Drugs
ISBN : UCSD:31822017248519
Author : Leif Schaumann,Stanford Research Institute
Publisher : Unknown
Page : 100 pages
File Size : 47,6 Mb
Release : 1979
Category : Developing countries
ISBN : UCSD:31822024349011
Author : United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology
Publisher : Unknown
Page : 1384 pages
File Size : 53,7 Mb
Release : 1979
Category : Drugs
ISBN : UOM:39015081270806
Author : Mark L. Flear,Anne-Maree Farrell,Tamara K Hervey,Thérèse Murphy
Publisher : Oxford University Press
Page : 477 pages
File Size : 44,8 Mb
Release : 2013-03-14
Category : Law
ISBN : 9780199659210
New health technologies promise great things but they also pose significant challenges for governments, particularly around safety concerns, effectiveness, and value for money. This collection analyses the defining features of the relationship between EU law and new technologies, and the roles of risk, rights, ethics, and markets.
Author : José Rodríguez-Pérez
Publisher : Quality Press
Page : 246 pages
File Size : 51,5 Mb
Release : 2014-08-15
Category : Business & Economics
ISBN : 9780873898690
This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.
Author : Jonathan Merrills,Jonathan Fisher
Publisher : John Wiley & Sons
Page : 418 pages
File Size : 50,7 Mb
Release : 2008-04-15
Category : Medical
ISBN : 9780470680377
This textbook explains what pharmacy students and practicing pharmacists need to know about pharmacy and the law, including recent changes in the National Health Service. The book provides easy accessibility amd concise, yet comprehensive information. There have been many changes in the NHS and in the law relating to pharmacy since the first edition was written. Therefore, the book has been thoroughly revised, and the text re-organized.