Download or read book Licensing of Drug product for European Union written by Sandeep Narayan Patil, PMP and published by Notion Press. This book was released on 2021-05-25 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the second book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book mainly discusses launch of drug products in EU market which are manufactured in countries like India or china by supplier manufacturer. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.

Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Download or read book A review of UK health research funding written by David Sir Cooksey and published by The Stationery Office. This book was released on 2006-12-06 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR).

Download or read book Private Patents and Public Health written by Ellen F. M. 't Hoen and published by . This book was released on 2016 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many. 0The AIDS crisis in the late nineties brought access to medicines challenges to the public?s attention, when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis ? 8,000 people dying daily ? the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of low-priced generic HIV medicines. 0But now, high prices of new medicines - for example, for cancer, tuberculosis and hepatitis C - are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises. 0This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book German Homoeopathic Pharmacopoeia written by and published by CRC Press. This book was released on 2003-11-03 with total page 838 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the increased popularity of alternative medicine, quality assurance and testing methods for alternative medicinal products has moved to the forefront of the field. And although regulation of these products varies from country to country, universally they are required satisfy the same quality requirements as the medicines used in allopathy. Filling the need for an authoritative resource, German Homoeopathic Pharmacopoeia contains monographs covering homoeopathic products and their related analytical and manufacturing techniques. Each monograph is uniformly structured supplying, where applicable: Origin Description Characteristics Identification Purity Tests Assays Basic dosage forms Manufacture Storage Completely revised and updated, the volumes put the latest information within easy reach. An extensive collection of manufacturing and testing techniques, German Homoeopathic Pharmacopoeia establishes standards to ensure the pharmaceutical quality and safety of homoeopathic medicinal products.

Download or read book Post Authorization Safety Studies of Medicinal Products written by Ayad K. Ali and published by Academic Press. This book was released on 2018-06-27 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approaches for causal interference from observational data. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. Readers will be able to effectively and efficiently design and interpret findings from post-authorization safety studies with the goal of improving the benefit-risk balance of a drug in order to optimize patient safety. - Discusses all types of observational studies in post-marketing drug safety assessment, from spontaneous reporting systems, to pragmatic trials, with examples from real-world settings - Presents various types of post-authorization safety studies - Offers solutions to the common challenges in the design and conduct of these studies - Highlights active surveillance programs, including common data models for rapid signal detection of drug safety issues

Download or read book Evaluating Pharmaceuticals for Health Policy and Reimbursement written by Nick Freemantle and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: “The challenge in all settings is to make the difficultdecisions in a way that is defensible, justifiable, ethical, andequitable” So write Nick Freemantle and Suzanne Hill in their introductionto this important discussion on decision making in thereimbursement of pharmaceuticals. Based around a programmesupported by the World Health Organization, chapters by leadingacademics involved in the research tackle such major issues asinternational pharmaceutical policy, tensions in licensingpolicies, priority setting, and relationships between thestakeholders. Chapters include Development of marketing authorisation procedures forpharmaceuticals Interpreting clinical evidence International pharmaceutical policy: health creation or wealthcreation? Development of fourth hurdle policies around the world Economic modelling in drug reimbursement Priority setting in health care: matching decision criteriawith policy objectives Tensions in licensing and reimbursement decisions: case ofriluzole for amytrophic lateral sclerosis Relationship between stakeholders: managing the war ofwords Medicine and the media: good information or misleadinghype? How to promote quality use of cost-effective medicines Using economic evaluation to inform health policy andreimbursement: making it happen and making it sustainable Pricing of pharmaceuticals Evaluating pharmaceuticals for health policy in low and middleincome country settings. Besides the controversial issues there is a wealth of practicalinformation including economic modelling and the experiences fromthe WHO programme, providing readers with workable examples. Thisis essential reading for clinical researchers in pharmaceuticalsand policy makers everywhere.

Download or read book New Health Technologies written by Collectif and published by OECD. This book was released on 2017-02-03 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report discusses the need for an integrated and cyclical approach to managing health technology in order to mitigate clinical and financial risks, and ensure acceptable value for money. The analysis considers how health systems and policy makers should adapt in terms of development, assessment and uptake of health technologies. The first chapter provides an examination of adoption and impact of medical technology in the past and how health systems are preparing for continuation of such trends in the future. Subsequent chapters examine the need to balance innovation, value, and access for pharmaceuticals and medical devices, respectively, followed by a consideration of their combined promise in the area of precision medicine. The final chapter examines how health systems can make better use of health data and digital technologies. The report focuses on opportunities linked to new and emerging technologies as well as current challenges faced by policy makers, and suggests a new governance framework to address these challenges.

Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Download or read book Pharmaceutical Medicine written by Adrian Kilcoyne and published by OUP Oxford. This book was released on 2013-05-23 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Regulatory Toxicology in the European Union written by Tim Marrs and published by Royal Society of Chemistry. This book was released on 2018-02-21 with total page 638 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consumer and environmental protection depend on the careful regulation of all classes of chemicals. Toxicology is the key science used to evaluate safety and so underpins regulatory decisions on chemicals. With the growing body of EU legislation involved in chemical regulation, there is a concomitant need to understand the toxicological principles underlying safety assessments Regulatory Toxicology in the European Union is the first book to cover regulatory toxicology specifically in Europe. It addresses the need for a wider understanding of the principles of regulatory toxicology and their application and presents the relationship between toxicology and legislative processes in regulating chemical commodities across Europe. This title has a broad scope, covering historical and current chemical regulation in Europe, the role of European agencies and institutions, and also the use of toxicology data for important classes of chemicals, including human and veterinary medicines, animal feed and food additives, biocides, pesticides and nanomaterials. This book is therefore extremely pertinent and timely in the toxicology field at present. This book is an essential reference for regulatory authorities, industrialists, academics, undergraduates and postgraduates working within safety and hazards, toxicology, the biological sciences, and the medicinal and pharmaceutical sciences across the European Union.

Download or read book Pharmacovigilance in the European Union written by Michael Kaeding and published by Springer. This book was released on 2017-02-20 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is open access under a CC BY 4.0 license. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations, and thereby contribute to a better understanding of the factors that incentivize or impede the practical implementation of EU law at the national level.

Download or read book Diagnostic Immunohistochemistry written by David J. Dabbs and published by . This book was released on 2002 with total page 690 pages. Available in PDF, EPUB and Kindle. Book excerpt: 17 world-renowned experts offer the most current information and reliable guidance on immunohistochemical diagnoses in surgical pathology and cytopathology. Introductory chapters cover cost modeling for immunohistochemistry and immunohistochemical techniques. The following chapters utilize an organ systems and diseases approach to diagnostic tumor pathology. "A newly updated book that our laboratory staff have found very useful in our day to day work" Reviewed by: PathLab.org, Sept 2014 "...It also acts as an up-to-date bench-top reference tool. It is an easy-to-read, wellpresented text that I would recommend as a 'must have' for every pathology department". Reviewed by: Dr Gemma Petts, Imperial College London on behalf of The Bulletin of The Royal College of Pathologists, Oct 2014 Consistently organized chapters for quick access to vital information Each chapter "stands alone," providing all the information you might need on a specific topic Quick-reference boxes summarize the most important diagnostic points at the end of each text Section Colour photographs and illustrations reinforce key diagnostic points

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Download or read book Oxford Handbook of Clinical and Healthcare Research written by Sumantra Ray and published by Oxford University Press. This book was released on 2016 with total page 603 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research.

Download or read book The Global Politics of Pharmaceutical Monopoly Power written by Ellen F. M. 't Hoen and published by . This book was released on 2009 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: In The Global Politics of Pharmaceutical Monopoly Power, researcher and global advocate Ellen 't Hoen explains how new global rules for pharmaceutical patenting impact access to medicines in the developing world. The book gives an account of the current debates on intellectual property, access to medicines, and medical innovation, and provides historical context that explains how the current system emerged. This book supports major policy changes in the management of pharmaceutical patents and the way medical innovation is financed in order to protect public health and, in particular, promote access to essential medicines for all. The Open Society Institute provided support to translate this report into Russian.